MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL A2; BIOTESTCELL 2

Catalog Number	816047100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
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 a weak false positive reaction of biotestcell-a2 with the anti-a1 lectin reagent of a competitor.The customer provided a sample of the allegedly defective product biotestcell-a2 for investigational testing and also the anti-a1 reagent.Our quality control laboratory tested the complaint sample as well as their retention sample of biotestcell a2 with the anti-a1 lectin reagent and could confirm the customer´s finding: the supposedly defective product yielded a weak false positive reaction.Additionally the complaint and the retention sample of biotestcell-a2 were tested with seraclone anti-a1 and yielded correctly negative reactions.The weak false positive reactions were only observed with the anti-a1 lectin reagent of a competitor.Based on this false positive reaction we initiated further actions.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL A2
• Common Device Name: BIOTESTCELL 2
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 8563627
• Report Number: 9610824-2019-00021
• Device Sequence Number: 11329705
• Product Code: KSZ
• UDI-Device Identifier: 07611969952625
• UDI-Public: (01)07611969952625(17)190408(10)8907011-00
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/30/2019

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: 816047100
• Device Lot Number: 89007011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1