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	04/01/2019
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 the complaint product sample, but not the anti-a1 reagent used in this testing.At the time we received the complaint sample on our premises, the supposedly defective product was already expired.Within its shelf life our quality control laboratory tested their retention sample of the allegedly defective lot of biotestcell a2 with the anti-a1 lectin reagent and could confirm customer´s finding: the supposedly defective product yielded a weak false positive reaction.Additionally biotestcell-a2 was tested with seraclone anti-a1 and yielded a correctly negative reaction.The weak false positive reaction was 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: 8563628
• Report Number: 9610824-2019-00020
• Device Sequence Number: 1822179
• Product Code: KSZ
• UDI-Device Identifier: 07611969952625
• UDI-Public: (01)07611969952625(17)190408(10)8907011-00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 04/01/2019
• 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