MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-1000 AUTOMATED ANALYZER SYSTEM

Catalog Number	001100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive reaction of a patient sample with the anti-b of ih-card abo/d(dvi-)+rev.A1, b on the ih-1000 during forward typing.The patient sample was re-tested on (b)(6) 2024 on the same instrument and was reported as o positive with no false positive reaction in the anti-b well.Trace files of the affected ih-1000 instrument were analyzed with the following results: the sample (b)(6) has been loaded at 15:53:53 on lane 5 position 3.The sample has been pipetted by the left pipettor.The needle has been washed before and after making the red blood cell suspension for the test.The red blood cell suspension has been pipetted from well 4 to 1, it means control, anti-d, anti-b and anti-a.The waiting time between the pipetting and centrifuging was 15 minutes 41 seconds.There was no error during the processing of sample.The processed gel card image does not present any anomalies, the result has been correctly interpreted by the algorithm.The previous sample pipetted by the left pipettor is (b)(6) with a b rhd positive result, also pipetted from well 4 to 1.In view of reviewed data, there is no indication for an instrument malfunction.The result on the sample (b)(6) seems to be related to a carry-over from the anti-sera of well 3 (anti-d) to well 2 (anti-b) causing the false positive on the anti-b well.As we do not have any pictures of gel control for this gel card, we cannot ensure that the gel card did not present any splashes of anti-sera before testing.The traces file show that some qc samples have been tested with this gel card lot and no complaint was raised on the qc test from the customer.So, there is no manufacturing issue with our product ih-card abo/d(dvi-)+rev.A1,b.
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.

• Brand Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Common Device Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• 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: 20555936
• Report Number: 9610824-2024-00050
• Device Sequence Number: 3250883
• Product Code: KSZ
• UDI-Device Identifier: 07611969205493
• UDI-Public: (01)07611969205493
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: BK170019
• 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): 10/29/2024

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 Catalogue Number: 001100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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-CARD ABO/D(DVI-)+REV A1,B LOT: LOT 9336010; IH-CELLA1&B, LOT 9434021
• Patient Sex: Unknown