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

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	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false negative reactions of patient samples with seraclone anti-d blend in the tube method immediate spin.The customer stated that the positive reactions with seraclone anti-d (rh1) blend are weaker than the reactions on the immucor echo instrument.The customer returned a sample of the allegedly defective product for investigational testing and also one patient sample.While our quality control laboratory was waiting for the material to arrive, they 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, the retention sample and the reference were tested with different samples for specificity.All positive and negative reactions were correct.We did not observe any false negative reaction.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.When our quality control laboratory received the customer's material, they tested the complaint sample for potency in parallel with the retention sample and a reference lot.All three reagent samples showed comparable results and met the minimum titer.Also, the complaint sample, retention sample and reference were tested with different samples for specificity.All positive and negative reactions were correct.We did not observe any false negative reaction.The patient sample was also tested with the complaint sample, the retention sample, and the reference.The patient sample showed weak positive reactions (2w) in the tube method immediate spin and strongly positive results in the indirect anti-globulin test (iat).Again, the results with complaint sample, retention sample and reference lot were comparable.The patient sample was sent for molecular rh(d) typing to an external laboratory.We are still waiting for the results.
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 false negative reactions of patient samples with seraclone anti-d blend in the tube method immediate spin.The customer stated that the positive reactions with seraclone anti-d (rh1) blend are weaker than the reactions on the immucor echo instrument.The customer returned a sample of the allegedly defective product for investigational testing and also one patient sample.While our quality control laboratory was waiting for the material to arrive, they 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, the retention sample and the reference were tested with different samples for specificity.All positive and negative reactions were correct.We did not observe any false negative reaction.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.When our quality control laboratory received the customer's material, they tested the complaint sample for potency in parallel with the retention sample and a reference lot.All three reagent samples showed comparable results and met the minimum titer.Also, the complaint sample, retention sample and reference were tested with different samples for specificity.All positive and negative reactions were correct.We did not observe any false negative reaction.The patient sample was also tested with the complaint sample, the retention sample, and the reference.The patient sample showed weak positive reactions (2w) in the tube method immediate spin and strongly positive results in the indirect anti-globulin test (iat).Again, the results with complaint sample, retention sample and reference lot were comparable.The patient sample was sent for molecular rh(d) typing to an external laboratory.The outcome of the investigation was: rhd 01el.32 / 01n.58.The polymorphisms detected in the rhd-specific introns 1 and 5 were associated with a del32 (ivs1).Sequencing of the rhd gene revealed two polymorphisms in non-coding gene regions.Sequencing of the rhd gene revealed two polymorphisms in non-coding gene regions.The variants were described (isbt terminology) as del or zero allele (rhd 01el.32 and rhd 01n.58).The rhesus base, on the other hand (including personal experience), indicated the relative frequency of these mutations.However, the occurrence of both polymorphisms in one sample is rare and might be the cause of a weakened rhd allele in this constellation.Based on the investigation the complaint was classified as confirmed - epp (expected product performance).The complaint sample and the retention sample reacted as expected.All acceptance criteria regarding potency and specificity were met.The patient sample showed correctly positive but slightly weakened results in the immediate spin test and strongly positive results the indirect antiglobulin test (iat).Additionally, the patient sample was sent for molecular rh(d) typing to an external laboratory.The result of the molecular genetic analysis of the affected sample could be an explanation of the weakened reaction in the immediate spin test.The instruction for use (ifu) contained an appropriate note in the section limitations: if the immediate reaction with anti-d (rh1) blend is negative, a 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.We pointed out to the customer that the cell buttons must dislodged gently after centrifugation.Otherwise, the agglutinates of weak positive reactions might be destroyed.

• Brand Name: BLOOD GROUPING REAGENT ANTI-D (RH1) BLEND
• Common Device Name: SERACLONE ANTI-D (RH1)
• 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: 18147372
• Report Number: 9610824-2023-00061
• Device Sequence Number: 6988343
• Product Code: QHR
• UDI-Device Identifier: 07611969950201
• UDI-Public: (01)07611969950201(17)240904(10)9237090-03
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/21/2024

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: 09/04/2024
• Device Catalogue Number: 802033100
• Device Lot Number: 9237090-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/22/2024
• 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