MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-A; SERACLONE ANTI-A

Catalog Number	801325100
Health Effect - Clinical Code	Reaction (2414)
Date of Event	07/15/2019
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 false positive reactions of four donor units when tested with seraclone anti-a.The customer claimed the units yielded blood group ab test results during re-typing when they were labelled as blood group b.The blood group b of the units was confirmed by re-tests using reagents of two different manufacturers.The customer returned two vials for the supposedly defective product seraclone anti-a for investigational testing and five donor samples (one edta sample and four segments).Our quality control laboratory tested both vials of the supposedly defective product returned by the customer with different donor samples for potency and specificity.All positive and negative reactions were correct.The minimum titer of 64 was exceeded.Furthermore the donor samples (one edta sample and four segments) provided by the customer were tested with the vials of the complaint sample.All samples reacted clearly negative even after a prolonged incubation time of 60 minutes which is not according to the instruction for use.We only observed a kind of sticky effect in the immediate spin method after the centrifugation when the cell buttons had to be dislodged to observe for agglutination.But nevertheless no agglutination was observed in the donor samples provided by the customer.The reactions were clearly negative.We can only assume that the sticky effect led to a misinterpretation of the result by the customer.Testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-a 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: BLOOD GROUPING REAGENT ANTI-A
• Common Device Name: SERACLONE ANTI-A
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 8882768
• Report Number: 9610824-2019-00046
• Device Sequence Number: 16236169
• Product Code: KSZ
• UDI-Device Identifier: 07611969950065
• UDI-Public: (01)07611969950065(17)200220(10)8808030-03
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/12/2019

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: 02/20/2020
• Device Catalogue Number: 801325100
• Device Lot Number: 8808030-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1