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

Catalog Number	802033100
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a patient sample that was typed as rhd negative using the immediate spin test.However, a reference lab typed the same patient as rhd positive using gel cards on automated instrument (ortho vision).The customer was not aware that according to the ifu a weak d test had to be performed in order to identify a weak/variant d antigen.The patient sample was retested and the customer obtained a positive reaction in the ahg phase.The customer announced to send in the patient sample for investigational testing.As of today, we have not yet received the patient material in order to confirm the assumption about the presence of a weak/variant d antigen.
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a patient sample that was typed as rhd negative using the immediate spin test.However, a reference lab typed the same patient as rhd positive using gel cards on automated instrument (ortho vision).We were not able to obtain any information regarding the method used at the reference lab.We also obtained no information regarding the date of event.The customer was not aware that according to the ifu a weak d test had to be performed in order to identify a weak/variant d antigen.The patient sample was retested and the customer obtained a positive reaction in the ahg phase.The customer initially announced to send in the patient sample for investigational testing but did actually not provide the patient material so that we could not confirm the assumption about the presence of a weak/variant d antigen.Our quality control department had already tested their retention sample of the supposedly defective lot for potency in parallel with a reference lot.Both reagent samples showed comparable results and met the minimum titer.Furthermore, retention sample and reference were tested with different samples for specificity in the method immediate spin.All positive and negative reactions were correct.Based on the investigation the complaint was classified as undetermined: the complaint sample was not available for investigation and the retention sample reacted as expected.All acceptance criteria regarding specificity and potency were met.Nevertheless we would like to refer to the following section of the instruction for use (ifu): "if the immediate reaction with anti-d (rh1) blend is negative after incubation at room temperature, an additional test for weak d or partial d may be performed".Very weak antigen expression may not be detected.There is no monoclonal anti-d reagent, which will detect all parts of the d antigen." 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 final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT ANTI-D (RH1) BLEND
• Common Device Name: SERACLONE ANTI-D (RH1) BLEND
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMNH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 20513218
• Report Number: 9610824-2024-00049
• Device Sequence Number: 7045377
• Product Code: QHR
• UDI-Device Identifier: 07611969950201
• UDI-Public: (01)07611969950201(17)250501(10)3313012-00
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2024

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: 05/01/2025
• Device Catalogue Number: 802033100
• Device Lot Number: 3313012-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown