MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

Catalog Number	816 014100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2017
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 she missed an anti-jk(a) when using biotest cell 1&2 on tango infinity during yearly correlation qc.The customer did not return the supposedly defective product biotest cell 1&2 for investigational testing but returned the patient sample which had caused a false negative test result.At the time the customer filed her complaint, the complaint the supposedly defective product was already expired.Therefore our qc lab's retention sample was not tested.Upon receiving the patient sample in (b)(4), our quality control laboratory tested their retained sample of the current biotest cell 1&2 lot with the patient sample on tango infinity and could confirm the customer´s result.Upon visual assessment the reaction was not clearly negative.Additionally the patient sample was tested in the tube technique and yielded a +/- reaction.The patient sample was also tested in the ih-gel method and yielded weak positive results.The positive reaction was a bit stronger when using enzyme treated reagent red blood cells in the ih-gel system.These test results strongly indicate that the missed anti-jk(a) is a weak reacting antibody.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." the current lot of biotest cell 1&2 was also tested with different samples and controls, e.G.An anti-jk(a).All positive and negative reactions were correct.We did not observe any false negative reaction.Testing by the quality control laboratory confirmed the allegedly defective lot of biotest cell 1&2 functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of both allegedly defective lots.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL 1&2
• Common Device Name: BIOTESTCELL 1&2
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6474753
• Report Number: 9610824-2017-00024
• Device Sequence Number: 19096220
• Product Code: KSZ
• UDI-Device Identifier: 07611969952380
• UDI-Public: 07611969952380
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2017
• Device Catalogue Number: 816 014100
• Device Lot Number: 8703011-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AHG, LOT 8631140-02 EXP. 01/25/2018; MLB 2, LOT 8624130-00, EXP. 06/06/2018; SOLIDSCREEN II STRIP, LOT 8629060 EXP. 07/15/2018; TANGO INFINITY, # 4230000158