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 Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false negative reaction of a patient sample with seraclone anti-d blend.The customer sent in the complaint sample of the supposedly defective lot for investigational testing and also patient material that had caused a false negative test result.Our quality control laboratory tested the complaint sample for potency and specificity in parallel with their retention sample of the allegedly defective lot and also a reference lot.The complaint sample met the minimum titer of 32.All three reagents (complaint sample, retention sample and reference lot) showed comparable results.All acceptance criteria were met.Both specimens provided by customer were tested in the immediate spin method: sample #(b)(6) showed a +/- reaction, while specimen #(b)(6) showed a 2+ positive reaction.In addition both specimens were tested in the indirect anti-globulin test according to the recommendation of the ifu and showed strong positive reactions.Based on the serological test results a weak d respectively d variant was suspected for both specimens.Therefore, they were sent for molecular rh(d) typing to an external laboratory.We are still waiting for the results.Due to the ongoing investigation, we are not in the position to provide a conclusive statement.The complaint sample as well as the retention sample of the supposedly defective lot reacted as expected.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 false negative reaction of a patient sample with seraclone anti-d blend.The customer sent in the complaint sample of the supposedly defective lot for investigational testing and also patient material that had caused a false negative test result.Our quality control laboratory tested the complaint sample returned by the customer for potency and specificity in parallel with their retention sample of the allegedly defective lot and also a reference lot.The complaint sample met the minimum titer of 32.All three reagents (complaint sample, retention sample and reference lot) showed comparable results.All acceptance criteria were met.Both specimens provided by customer were tested in the immediate spin method: sample #: (b)(6) showed a +/- reaction, while specimen #t1800346 showed a 2+ positive reaction.In addition both specimens were tested in the indirect anti-globulin test according to the recommendation of the ifu and showed strong positive reactions.Based on the serological test results a weak d respectively d variant was suspected for both specimens.Therefore, they were sent for molecular rh(d) typing to an external laboratory.Both samples were typed as ccddee.The subsequent sequencing of the rhce gene did not show any mutation that could explain d-like structures that might be mimicked by rhce protein carrying amino acid substitutions.Based on the investigation and the provided information the complaint was classified as confirmed - epp (expected product performance).The complaint sample as well as the retention sample reacted as expected.The unexpected positive reactions (unexpected with regard to the genotype ccddee) occurred only with the patient samples provided by customer.The positive reactions might be explainable due to the five red blood cell units the patient received in (b)(6) 2021.The patient was transfused with a rhd positive blood.Bio-rad currently assume that the mixed field reaction in gel card on (b)(6) and the positive reactions in tube test might be explainable due to the five red blood cell units the patient received in (b)(6) 2021.The survival and lifespan measurements obtained with transfused erythrocytes indicating an overall good survival with a maximum of 135 days after transfusion (bosman gj.Survival of red blood cells after transfusion: processes and consequences.Front physiol.(b)(6) 2013 dec 18;4:376).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
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 12655317
• Report Number: 9610824-2021-00068
• Device Sequence Number: 14572946
• Product Code: QHR
• UDI-Device Identifier: 07611969950201
• UDI-Public: (01)07611969950201(17)230112(10)9103110-01
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 01/12/2023
• Device Catalogue Number: 802033100
• Device Lot Number: 9103110-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown