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; 48 CARDS

Catalog Number	813111100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Reaction (2414); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported unexpected negative reactions in the reverse cell wells of ih-card abo/d(dvi-) when used on ih-1000.The images appeared to be double population (dp) but the interpretations were negative.The customer returned the ih-1000 files for investigation but has so far not communicated which lot number he used for his testing.The investigation is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported one unexpected negative reaction with ih-cell b in the reverse grouping of ih-card abo/d(dvi-) when used on the ih-1000 instrument.The result was expected to be positive.The patient sample that caused the false negative test result was not available for investigation.But the customer returned the ih-1000 files.The image of the false negative reaction appeared to be a double population (dp) with fibrin on top and through the gel, but the interpretation was negative.Based on the investigation of the instrument files the complaint was classified as confirmed - epp.It seemed that the result was negative due to a patient with weak isoagglutinin.The interpretation was linked to the algorithm image analysis and was in the specifications of this test.A malfunction of the instrument was excluded.Due to the discrepancy between forward and reverse typing the ih-1000 stated, "abo not interpretable" and no incorrect results were released.The patient sample affected was not available for testing.However, we would like to refer to the chapter limitations of the ifu (instruction for use), where it is stated: "decreased abo antibody reactivity may be seen with low titer isoagglutinin antibodies may be caused by disease states, the elderly or infants resulting in false negative reactions.".

• Brand Name: BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B
• Common Device Name: IH-CARD ABO/D(DVI-)+REV A1,B; 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: 9313827
• Report Number: 9610824-2019-00061
• Device Sequence Number: 16700261
• Product Code: QHR
• UDI-Device Identifier: 07611969952090
• UDI-Public: (01)07611969952090
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 02/23/2023
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 813111100
• Device Lot Number: UNKNOWN
• 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: 10/16/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 CELL I-II-III, LOT NUMBER UNKNOWN; IH CELL I-II-III, LOT NUMBER UNKNOWN; IH-1000; IH-1000
• Patient Sex: Unknown