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	813112100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive reaction in the anti-b well for one patient sample of blood type a rhd positive.Testing was conducted on the customers ih-1000 instrument.The customer did not provide a sample of the allegedly defective product for investigational testing nor the patient sample that had caused the false positive test result.Therefore, our quality control laboratory tested their retention sample of the affected lot.First, all cards from the retention sample were visually checked regarding the sealing foil, the presence of supernatant and the gel homogeneity and showed no abnormalty.For the serological testing, 5 donors (blood group a) with negative specificity in the anti-b cavity, as well as one donor (blood group b) with positive specificity in the anti-b were tested on the ih-1000.Additionally, two samples of the ih_basic qc set that the customer had used during his tests were also used for this test.All results were correct.No false positive reactions in the anti-b cavity occurred, all six donor bloods reacted correctly.No manufacturing-related quality issue with the cards were noticed.Trace files of the affected ih-1000 instrument were analyzed and no instrument-related issues were detected.Upon comprehensive tracefile analysis, we observed that well no 2 (anti-b) was dispensed after well no.3 (anti-d).We strongly assume that the false positive reaction in the anti-b well occurred due to inter-well carry-over; specifically, reagent drop contamination with anti-d (patient a+) led to a false positive result in the anti-b well.
Additional Manufacturer Narrative
This is our combined initial and 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
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 21534487
• Report Number: 9610824-2025-00006
• Device Sequence Number: 15418188
• Product Code: QHR
• UDI-Device Identifier: 07611969964529
• UDI-Public: (01)07611969964529(17)260221(10)9443010
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: 02/21/2026
• Device Catalogue Number: 813112100
• Device Lot Number: 9443010
• 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: 02/12/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: IH-1000, SN (B)(6).; IH-BASIC QC, LOT: 9978980072.
• Patient Sex: Unknown