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

Catalog Number	813181100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false positive test result with ih-card abo/d(dvi-)-conf when used on ih-1000.The anti-a well yielded an 1+ test result but the patient is supposedly an o positive patient.The instrument called the test result "abo not interpretable" and no false test result was released.Investigation and testing of this complaint in our quality control laboratory is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported several issues with false positive results involving ih-card abd(dvi-)-conf on the ih-1000.The customer stated that the software interpretation was 1+ positive, when the images were clearly negative.The customer did neither return the supposedly defective product for investigational testing nor the patient sample that had caused the false positive test result.Therefore our quality control laboratory checked their retention sample of the allegedly defective product lot visually and all acceptance criteria were met.The specifications were: visible supernatant homogeneous gel intact sealing no splashes in the reaction chamber furthermore, several cards of the retention sample of the supposedly defective product ih-card abd(dvi-)-conf were tested with donor samples on ih-1000.No false positive reactions were observed.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.According to our sop the complaint was classified as undetermined: the complaint sample was not available, and the retention sample reacted as expected.The customer provided images, but not for this specific ih-card.No data files were provided for this ih-card.As we did not receive the affected patient material and the trace files, further investigations could not be done.

• Brand Name: BLOOD GROUPING REAGENT IH-CARD ABD(DVI-)-CONF
• Common Device Name: IH-CARD ABD(DVI-)-CONF; 48 CARDS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 10487283
• Report Number: 9610824-2020-00062
• Device Sequence Number: 3055142
• Product Code: QHR
• UDI-Device Identifier: 07611969952120
• UDI-Public: (01)07611969952120(17)210612(10)8007080
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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: 06/12/2021
• Device Catalogue Number: 813181100
• Device Lot Number: 8007080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 06/01/2021
• 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 1000, SN 5100073; IH 1000, SN 5100073; IH-CARD ABO/D(DVI-)+REV A1,B, LOT 8013040; IH-CARD ABO/D(DVI-)+REV A1,B, LOT 8013040; IH-CARD ABO/D(DVI-)+REV A1,B, LOT 8016010; IH-CARD ABO/D(DVI-)+REV A1,B, LOT 8016010