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	813191100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that a unit was typed as b rh(d) negative when using ih-card abd (dvi+) conf.On ih-1000.This unit was labelled as o rh(d) negative.The blood group o was confirmed in a manual test method.The customer did neither return the supposedly defective product for investigational testing nor the patient sample that had caused a false positive test result.Our quality control laboratory is still testing the retention sample of the supposedly defective product.Investigation of the provided instrument documentation is still ongoing.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.
Event or Problem Description
The customer reported that a donor unit was typed as b rh(d) negative with ih-card abd(dvi+) conf.On the analyzer ih-1000.The unit was labelled as o rh(d) negative.The blood group o was confirmed in a manual test method.The customer did neither return the supposedly defective product for investigational testing nor the patient sample that had caused the false positive reaction in the anti-b well.However, the corresponding trace files and the image were provided.The result image showed that there were little to no red bloods in all wells.The trace file analysis showed that the false positive result was due to haemolysis of the dilutions distributed in the well.That obscured the gel.During a customer visit it was noted that the customer incorrectly diluted the packed red cells from the donor blood bag segments prior to testing on the ih-1000.This led to a weaker concentration and smaller pellet.The users were re-trained not to dilute the samples before testing.The customer confirmed shortly after escalation of the complaint that the complaint was caused by an user error, meaning that they had diluted the red cells of the donor unit prior to testing.The customer was advised to follow the instruction for use.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.No further complaints regarding this lot were reported.The investigations showed that the complaint was a clear user error.

• 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, hessen 63303 ; GM 63303
• MDR Report Key: 8477710
• Report Number: 9610824-2019-00009
• Device Sequence Number: 11440343
• Product Code: QHR
• UDI-Device Identifier: 07611969952137
• UDI-Public: (01)07611969952137(17)190408(108749090
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 04/08/2019
• Device Catalogue Number: 813191100
• Device Lot Number: 8749090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/03/2019
• 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-1000, # 5100086; IH-1000, # 5100086