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	07/23/2018
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 a false negative result of a patient sample when tested with biotestcell 3 on tango infinity.The customer stated that the specificity of the known antibody is anti-k.The customer returned the supposedly defective product biotestcell 3 for investigational testing and also the patient sample that had caused a false negative test result.The customer also returned the anti-human globulin (ahg) anti-igg solidscreen ii.At the time we received the customer's biotestcell 3 sample the supposedly defective product was already expired.Therefore our quality control laboratory tested the patient sample with their retention sample of the current lot of biotestcell 3 and the ahg anti-igg solidscreen ii returned by the customer on tango infinity.The patient sample yielded a correct positive result with the kell positive cell #2 of biotestcell 3.Additionally the customer's ahg anti-igg solidscreen ii of customer was tested for potency and specificity and met all acceptance criteria.During its shelf life the retention sample of the supposedly defective biotestcell 3 lot was tested with different samples and controls on tango infinity, e.G.Anti-k from an interlaboratory test.All positive and negative reactions were correct.We did not observe any false negative reaction.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 both allegedly defective lot.The affected tango infinity was inspected by our field service engineers and found to be working within specifications.

• 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: 7796962
• Report Number: 9610824-2018-00049
• Device Sequence Number: 11056551
• Product Code: KSZ
• UDI-Device Identifier: 07611969952687
• UDI-Public: (01)07611969952687(17)180730(10)8823021-00
• 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): 08/20/2018

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: 07/30/2018
• Device Catalogue Number: 816085100
• Device Lot Number: 8823021-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1