MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT IH-CARD ANTI-D (DVI+); IH-CARD ANTI-D (DVI+); 48 CARDS

Catalog Number	813251100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported weak positive results with the anti-d instead of clearly negative results on ih-1000 when using the ih-card anti-d (dvi+).Originally, the customer stated that he observed this issue with hemobioscience control qc3 which is supposed to be rhd negative.The customer provided a product sample of the affected ih-card anti-d (dvi+) for investigational testing.Our quality control laboratory is currently testing the complaint sample in parallel with their retention sample of the supposedly defective lot on ih-1000.This testing is ongoing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Also still ongoing is an analysis of the trace files of the affected instrument ih-1000.
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 weak positive results with the anti-d instead of clearly negative results when testing with the e ih-card anti-d (dvi+) on the ih-1000 instrument.Originally, the customer stated that he observed this issue only with hemobioscience control qc3 which is supposed to be rhd negative.The customer provided a sample of the allegedly defective product ih-card anti-d (dvi+) for investigational testing and also the hemobioscience qc 3.The hemobioscience qc3 was already expired when we received it on our premises.Our quality control laboratory visually checked the cards returned by the customer and their retention sample of the supposedly defective lot.All acceptance criteria with regard to intact sealing, correct filling height, homogeneous gel and the absence of splashes in the reaction chamber were met.We observed only a slightly reduced supernatant in both the complaint sample and the retention sample which had no negative impact.Additionally our quality control laboratory tested the complaint sample and their retention sample of the supposedly defective lot with different donor samples on the ih-1000.In total we tested 48 ih-cards of the supposedly defective lot.Due to the reason for the complaint, the focus was on the testing of rhd negative samples on the ih-1000.In some cases the reaction were assessed as question mark and not as clearly negative.This evaluation was plausible due to single red blood cells in the gel column above the pellet.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The data files of the affected ih-1000 instrument were analyzed.Within the investigation of the data we observed that the issue also occurred with patient samples.The interpretation "?" or "+" by the instrument was confirmed and is justified due to the presence of few agglutinations above the pellet.Based on the investigation the complaint was classified as confirmed - upp (unexpected product performance).Based on the test results and the analysis of the data files the complaint had to be confirmed.However, the section interpretation of results of the instruction for use contained the following note:" *a very weak reaction is not an expected result for antigen testing.It may indicate that a false positive or a very weak/partial expression of the antigen is present.Further investigation of this sample should be performed before the antigen status is determined." the observed and confirmed issue has already been addressed and documented in internal quality notification (b)(4).

• Brand Name: BLOOD GROUPING REAGENT IH-CARD ANTI-D (DVI+)
• Common Device Name: IH-CARD ANTI-D (DVI+); 48 CARDS
• 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: 15354460
• Report Number: 9610824-2022-00055
• Device Sequence Number: 20402469
• Product Code: QHR
• UDI-Device Identifier: 07611969962402
• UDI-Public: (01)07611969962402(17)230130(10)9201080
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: 125097
• 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): 10/13/2022

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: 01/30/2023
• Device Catalogue Number: 813251100
• Device Lot Number: 9201080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 09/05/2022
• Supplement Report FDA Received Date: 10/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEMO QC#3, LOT 2206211.; HEMO QC#3, LOT 2206211.; IH-1000, SN (B)(6). ; IH-1000, SN (B)(6).
• Patient Sex: Unknown