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

Catalog Number	801325100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false positive results with anti-a when donor samples were tested as a negative with the reagent of a competitor.The customer used a 4% suspension of unwashed segments and performed the method immediate spin.The customer returned three segments of donor units for investigational testing and also the supposedly defective product seraclone anti-a.Testing in our quality control laboratory is still ongoing.We are therefore not yet in the position to provide a conclusive statement.Root cause analysis is still ongoing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Event or Problem Description
The customer reported false positive results with anti-a when donor samples were tested as a negative with the reagent of a competitor.The customer used a 4% suspension of unwashed segments and performed the method immediate spin.The customer returned the supposedly defective product seraclone anti-a for investigational testing and one donor sample that had caused false positive reactions.The donor sample was provided as three segments (pigtails) labeled as (b)(6).Our quality control laboratory tested the donor sample with the supposedly defective product in the method immediate spin according the instruction for use and yielded a weak positive reaction.The complaint sample provided by the customer was tested for potency and specificity.All acceptance criteria were met.The minimum titer of 64 was exceeded.Because the segments did not contain any serum or plasma reverse typing and testing for irregular red cell antibodies were not possible.Therefore the possible influence of an antibody could not be excluded.Due to the fact that segments (pigtails) are not suited for the molecular typing the segments could not be sent to an external laboratory for molecular abo typing.The weak positive reaction of the donor sample might be explained by the note in the chapter "specific performance characteristics" of the instruction for use: "seraclone anti-a has the ability to detect minute quantities of a-antigens on red cells (e.G.Ax).However, this capability allows clinical insignificant's numbers of a antigens to be detected as in rare cases of b individuals with elevated a antigen level (e.G.B(a) phenomena.Testing by our quality control laboratory confirmed 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.Based on the test results with this particular donor sample the complaint is classified as confirmed - expected product performance epp.The phenomenon escalated by customer has been confirmed, but it is not caused by any defect in the product and the instruction for use contain a corresponding hint, therefore, no further actions were necessary.
Additional Manufacturer Narrative
This is our final report on this incident.

• 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: 10091538
• Report Number: 9610824-2020-00027
• Device Sequence Number: 14116886
• Product Code: QHR
• UDI-Device Identifier: 07611969950065
• UDI-Public: (01)07611969950065(17)200907(10)8838030-03
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: 09/07/2020
• Device Catalogue Number: 801325100
• Device Lot Number: 8838030-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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: SERACLONE ANTI-A, LOT 8930090-07; SERACLONE ANTI-A, LOT 8930090-07