MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPE S ABD+REV A1,B

Catalog Number 806127100

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

This is our combined initial and final report on this incident.

Event Description

The customer reported about an unexpected positive blood typing result for rh d (clone bs226 and clone bs232) using erytype s abdreva1b, lot 8823210 when testing one patient sample on tango infinity.This patient got a historical typing of rh d negative.The customer described that both d wells showed large oversized buttons, approximately twice the size they had expected as reaction.The customer repeated the rhd testing of the patient sample on the bench and received a negative test result.The customer did return the patient sample that had caused the false positive test results and did return the supposedly defective product for internal investigation.In addition he provided the result images that confirm the positive results for rh d type.Our quality control laboratory tested the patient sample that had caused the unexpected positive result with the complaint sample of erytype s abd+rev.A1, b on tango infinity.The patient sample was showing correctly negative results with both anti-d reagents (clone bs226 and clone bs232) of erytype s abd+ rev.A1, b on tango infinity.The visual evaluation of the images of the respective wells revealed small fibrin clots.They neither had an impact to the visual assessment nor the analysis of the instrument.The reactions were assessed as clearly negative.For further investigation the supposedly defective sample of erytype s abd+rev.A1, b was tested with different donor samples using tango optimo.All positive and negative reactions showed correct test results.Our quality control did not observe any false positive reaction.Testing by the quality control laboratory confirmed the correct function of the allegedly defective lot of erytype s abd+rev.A1, b.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.Regarding the affected tango infinity: the last annual preventive maintenance was performed as per checklist on 10/25/2018.The log files did not show any issue relevant abnormalities, but revealed a high number of washer dispense warnings.The technical engineer mentioned a wash issue, but stated, that this does not affect any erytype test.No indication for an instrument malfunction could be identified on current data.It was confirmed that the instrument is working within specifications.The reported problem is likely related to sample specificities, because fibrin was considered that may have caused false positive rh d test results at customer´s site.It was confirmed that this issue was present with only one sample and that the rh d type could be correctly determined with other patients samples.

• Brand Name: ERYTYPE S ABD+REV A1,B
• Type of Device: ERYTYPE S ABD+REV A1,B
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 8514243
• MDR Text Key: 152944690
• Report Number: 9610824-2019-00018
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK040070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 806127100
• Device Lot Number: 8823210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1