MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL 3

Catalog Number 816085100

Device Problems False Negative Result (1225); Defective Device (2588)

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

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a discrepant result when performing antibody screen and antibody identification of a patient with a known anti-e on tango infinity.The homozygous e positive reagent red blood cell #2 (p2) of biotest cell 3 #8711021-00 reacted negative.Performing an antibody identification test, reagent red blood cell #2 (i-2) of biotest cell-i8 (homozygous) was 1+ positive.The customer did not return the supposedly defective product that had caused false negatives for investigational testing.Therefor our quality control laboratory tested their retained biotest cell 3 sample by using the same reagents that were specified by the customer with three known anti-e antibodies and controls on tango infinity and obtained correct results.The antibody anti-e was clearly found.Additionally, all reagents that were specified by the customer were tested and worked as expected.Then the customer sent in the patient sample for investigational testing and it was tested with the current lot biotest cell 3, because the affected lot was already expired.The antibody screen and the antibody identification were positive with all homozygous red blood cells.All positive and negative controls reacted as expected.The antibody was not detected when the id-card system was used.We strongly assume that the antibody that was found is a weak igm anti-e, that can frequently only be detected by enzyme testing.The instruction for use contains a corresponding note: "negative reactions will be obtained if the sample contains antibodies present in concentrations too low to be detected by the test method employed.No test method is capable of detecting all red cell antibodies." testing by our quality control laboratory confirmed that the allegedly defective lot of biotest cell 3 functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The affected tango infinity was inspected by one of our field service engineers with no indication for a malfunction.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL 3
• Type of Device: BIOTESTCELL 3
• 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 ; 103 3130 5
• MDR Report Key: 6583816
• MDR Text Key: 76027418
• Report Number: 9610824-2017-00033
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969952687
• UDI-Public: (01)07611969952687(17)170508(10)8711021-00
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2017
• Device Catalogue Number: 816085100
• Device Lot Number: 8711021-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2017
• Initial Date FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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