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 813121100

Device Problems False Positive Result (1227); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2020

Event Type  malfunction  

Manufacturer Narrative

This is our combined initial and final report on this incident.

Event Description

The customer reported a false positive result of one patient sample ((b)(6)) with the anti-b and the control of the ih-card abo/d(dvi+)+rev.A1, b on ih-1000 (b)(4).The customer stated that the manual testing with the same card lot and same specimen yielded a correct result.Due to the discrepancy between forward and reverse typing and the false positive reaction with the control the ih-1000 stated "a discrepancy has been identified" and no incorrect result was released.Within the investigation of the trace files we became aware that another sample showed a similar issue on (b)(6) 2020: sample (b)(6) showed a false positive result with the anti-b and the control of the ih-card abo/d(dvi+)+rev.A1, b lot 8924050 on ih-1000 (b)(4).The customer returned trace files for investigation, but neither the complaint samples of the supposedly defective products nor the patient samples that had caused the false positive results.Therefore our quality control laboratory tested their retention samples of both supposedly defective lots with different donor samples on ih-1000.All positive and negative results were correct.We did not observe any false positive reaction.The traces files of the affected ih-1000 have been analysed.The outcome of the investigation was: in the data provided by the customer, we could not check events regarding sample ((b)(6)) tested on (b)(6) 2020.However, we have been able to carry out checks on another sample ((b)(6)) tested on (b)(6) 2020, and which shows similar issue to that one described in the case.On (b)(6), tests were performed on the ih-1000 device's left robot pipettor side.We could confirm the customer's findings on the sample # (b)(6).During forward test on cards checked, wells were dispensed from the control well to anti-a.This allows to exclude inter well carry over, at least for ctrl well which was the first dispensed.In the provided data, we could also see that there was another sample processed in the same batch.That sample is identified with the number # (b)(6) and was dispensed on ih-card # (b)(6).This patient is blood group b and has anti-a antibodies.We assume that, as the forward test was performed first on the sample (b)(6), there were anti-a antibodies still stickled to the needle during red blood cells dilution of the following sample # (b)(6).So anti-a antibodies could have sensitized that following sample red cells and explain why there were false positive wells returned.As a preventive action, we highly recommend to the customer: to check the device's left robot pipettor needle and adjust it as recommended in service manual; it should be replaced if it was bent or the coating was damaged.Washing pot must be also be cleaned, without any sign of leakage.Testing by our quality control laboratory confirmed that the allegedly defective lots of ih-card abo/d(dvi+)+rev.A1, b function correctly.The false positive reactions might be caused by a contamination.Therefore a maintenance of the instrument is highly recommended.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lots.

• Brand Name: BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI+)+REV A1,B
• Type of Device: 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: 9956843
• MDR Text Key: 242608256
• Report Number: 9610824-2020-00015
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969952106
• UDI-Public: (01)07611969952106(17)200909(10)8919060
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2020
• Device Catalogue Number: 813121100
• Device Lot Number: 8919060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1