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

Catalog Number	816085100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported that they were using biotestcell 3 with ortho gel cards and they were worried that they would not pick up weak antibodies on heterozygous cells.The customer stated that a patient sample yielded a 1+ positive reaction with cell #1 of biotestcell 3.The antibody seemed to be a weak reacting anti-jk(a) and due to the specificity the patient sample was supposed to react positive also with cell #3.The customer also tested the patient sample with biotestcell 3 in the tube method and received a negative reaction.The customer did not return the supposedly defective product for investigational testing but the patient sample that had caused a false negative test result.Therefore our quality control laboratory tested the patient sample with biotestcell 3 in the ih-gelcard and could confirm the customer´s finding: the jka homozygous (jka+b-) cell #1 reacted positive while the jka heterozygous cell (jka+b+) cell #3 showed a negative result.Additionally the patient sample was tested in the tube technique and yielded completely negative results.Furthermore the retention sample of biotestcell 3 was tested with an anti-jka.Both, cell #1 and #3 showed correctly positive results.Additionally the retention sample of biotestcell 3 was tested with different samples and controls.All positive and negative reactions were correct.We did not observe any false negative reaction.Based on the test results a weak reacting antibody is very likely.The section "limitation" of the instruction for use contains the corresponding notes: "because some antibodies show dosage effect, the antigen density on the reagent red blood cells needs to be considered when evaluating the test results (homozygous or heterozygous hereditary disposition).A heterozygous expression of the antigen may result in non-detection of weak antibodies depending on the test method used.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 biotestcell 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.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL 3
• Common Device Name: BIOTESTCELL 3
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 8499473
• Report Number: 9610824-2019-00012
• Device Sequence Number: 11431769
• Product Code: KSZ
• UDI-Device Identifier: 07611969952687
• UDI-Public: (01)07611969952687(17)190408(10)8907021-00
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2019
• Device Catalogue Number: 816085100
• Device Lot Number: 8907021-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1