MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-D (RH1) BLEND; SERACLONE® ANTI-D (RH1) BLEND; 10X10ML

Catalog Number	802033100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a weak false positive reaction of a cap survey sample with seraclone anti-d blend when used manually.The reagent of a competitor gave a negative test result.The customer sent in the complaint sample seraclone anti-d blend for investigational testing, the cap survey sample j-05r that had caused the false positive test results and the anti-d reagent of the competitor (quotient albaclone anti-d blend, v215859).The investigation of the complaint sample as well as of the retention sample is ongoing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Additional Manufacturer Narrative
This is our initial report on this incident.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported a weak false positive reaction of a cap survey sample with seraclone anti-d blend when used manually.The reagent of a competitor gave a negative test result.The customer sent in the complaint sample seraclone anti-d blend for investigational testing, the cap survey sample j-05r that had caused the false positive test results and the anti-d reagent of the competitor (quotient albaclone anti-d blend, (b)(6)).Our quality control laboratory tested the complaint sample in parallel with their retention sample and a reference lot for potency.All three reagents met the minimum titer of 32 and showed comparable results.The cap survey sample was tested with the complaint sample, the retention sample, the reference lot and quotient albaclone anti-d blend.For these tests the cap survey sample was used ready for use and washed.The used test methods were immediate spin and the indirect antiglobulin test (iat, 30 min at 37°c).The cap survey sample showed negative results in all tests.Additionally, the cap survey sample was tested with ih-anti-d blend in the ih-card ahg anti-igg, in the ih-card dvi+ and in the ih-card dvi-.Again, all results were clearly negative.The customer's weak false positive results could not be reproduced in our of the quality control laboratory.Based on the investigation the complaint was classified as unjustified: the complaint sample as well as the retention sample reacted as expected.The cap survey sample showed correctly negative results in all tests performed.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-D (RH1) BLEND
• Common Device Name: SERACLONE® ANTI-D (RH1) BLEND; 10X10ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 11920690
• Report Number: 9610824-2021-00037
• Device Sequence Number: 16355614
• Product Code: QHR
• UDI-Device Identifier: 07611969950201
• UDI-Public: (01)07611969950201(17)210826(10)8936080-02
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: 125223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 07/23/2021

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: 08/26/2021
• Device Catalogue Number: 802033100
• Device Lot Number: 8936080-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1