MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI+)+REV A1,B; IH-CARD ABO/D(DVI+)+REV A1,B; 288 CARDS

Catalog Number	813122100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a rhd discrepancy of one patient sample during her validation activities with the ih-reader 24.The patient sample was tested in the ih-card abo/d(dvi+)+rev.A1, b and the anti-d (vi+) yielded a strong positive result.The sample was also tested in the abd card of a competitor and the tube test and yielded negative results.The customer did not return the complaint sample for investigational testing, but the patient sample ((b)(6)) that had caused the discrepancy.Therefore, our quality control laboratory tested the patient sample with their retention sample of the supposedly defective lot, and could confirm the customer´s finding: the sample yielded a 4+ positive reaction with the anti-d(vi+).The patient sample was also tested on the ih-card abd(dvi-) and yielded a negative result with the anti-d(vi-).Additionally the patient sample was tested for rhd in the tube technique and yielded a positive result only in the indirect antiglobulin test (iat) with seraclone anti-d blend.Based on the serological test results the rh(d) factor of the patient was supposed to be d cat.Vi.Therefore, the patient sample was sent out for rhd molecular typing to an external laboratory.We are still waiting for the result.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 a rhd discrepancy of one patient sample during her validation activities with the ih-reader 24.The patient sample was tested in the ih-card abo/d(dvi+)+rev.A1, b and the anti-d (vi+) yielded a strong positive result.The sample was also tested in the abd card of a competitor and the tube test and yielded negative results.The customer did not return the complaint sample for investigational testing, but the patient sample (b)(6) that had caused the discrepancy.Therefore our quality control laboratory tested the patient sample with their retention sample of the supposedly defective lot and could confirm the customer´s finding: the sample yielded a 4+ positive reaction with the anti-d(vi+).The patient sample was also tested on the ih-card abd(dvi-) and yielded a negative result with the anti-d(vi-).Additionally the patient sample was tested for rhd in the tube technique and yielded a positive result only in the indirect antiglobulin test (iat) with seraclone anti-d blend.Additionally the retention sample was tested with different donor samples.All positive and negative reactions were correct.Based on the serological test results the rh(d) factor of the patient was supposed to be d cat.Vi.Therefore the patient sample was sent out for rhd molecular typing to an external laboratory.The outcome of the external investigation was: ccd.Ee d cat.Vi type 3 (isbt: rhd*06.03.01).Based on this rh(d) type the patient sample showed a correctly positive result with the anti-d (vi+) of the ih-card abo/d(dvi+)+rev.A1, b.The rh(d) phenotype of the sample also explained the negative reaction with the anti-d of the ortho card, which is not able to detect the partial d cat.Vi epitope variant of the d antigen according to the information of the instruction for use.Due to the different reaction mode of both different anti-d clones (bio-rad and ortho) results within a validation might not be comparable.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 IH-CARD ABO/D(DVI+)+REV A1,B
• Common Device Name: IH-CARD ABO/D(DVI+)+REV A1,B; 288 CARDS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 10647414
• Report Number: 9610824-2020-00068
• Device Sequence Number: 2963687
• Product Code: QHR
• UDI-Device Identifier: 07611969964543
• UDI-Public: (01)07611969964543(17)210611(10)8007070
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: 125534
• 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): 11/25/2020

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: 06/11/2021
• Device Catalogue Number: 813122100
• Device Lot Number: 8007070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/25/2020
• 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: IH READER 24, # 139320503.; IH READER 24, # 139320503.; IH READER 24, # 139320503