The customer contacted beckman coulter, inc. (bec) to report the coulter act diff 2 analyzer generated erroneous elevated platelet (plt) results with instrument generated flags for one (1) patient. The initial plt result of 142 was reported out of the laboratory. A rerun of the sample produced a plt result of 137. A manual slide was performed and the plt result was 39. The patient specimen was tested at a reference lab and also produced a plt result of 39. This result was considered to be correct. Initial and rerun results were flagged with instrument generated aperture and voteout flags that alert the operator to further review the sample. No death, injury or change to patient treatment was reported in connection with this customer feedback.
Manufacturer Narrative
Patient specimen was collected via venipuncture in a 3. 0 ml bd vacutainer tube. Quality control (qc) was run before but not after the reported incident and results were within qc specifications. The field service engineer (fse) checked qc results and found a high spike on the plt histogram for all three levels of controls. There was no noise or interference spike at the 2 fl mark on the plt histogram during background check and total background test was found to be within specifications. The fse replaced the aspiration probe, performed latex aperture current verification and the verified instrument performance. Instrument was validated and all tests passed within specifications. Per product labeling, if any flag appears, review the results according to your laboratory's protocol. An x flag indicates that one of the multiple aperture alert criteria was not met. A * flag/code indicates a questionable result. If on plt, mpv (pct and pdw) only, plt < 20 x 103/ul, or platelet distribution failure non-positive curve mode <3 or > 15 fl pdw > 20 voteout of fitted curve sweepflow error.
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Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
BECKMAN COULTER, INC.
11800 sw 147th avenue
miami FL 33196
Manufacturer (Section G)
BECKMAN COULTER, INC.
11800 sw 147th avenue
miami FL 33196
Manufacturer Contact
dung nguyen
250 s kraemer blvd
brea , CA 92821
7149614941
MDR Report Key
2353930
Report Number
1061932-2011-02414
Device Sequence Number
1
Product Code
GKZ
Report Source
Manufacturer
Source Type
Health Professional,User facility
Reporter Occupation
HEALTH PROFESSIONAL
Type of Report
Initial
Report Date
03/16/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received
12/01/2011
Is This An Adverse Event Report?
No
Is This A Product Problem Report?
Yes
Device Operator
HEALTH PROFESSIONAL
Device MODEL Number
ACT DIFF 2
Device Catalogue Number
6605500
OTHER Device ID Number
SW VERSION 2.01
Was Device Available For Evaluation?
Yes
Is The Reporter A Health Professional?
Yes
Date Manufacturer Received
03/16/2011
Was Device Evaluated By Manufacturer?
Yes
Date Device Manufactured
05/01/2007
Is The Device Single Use?
No
Is this a Reprocessed and Reused Single-Use Device?