MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV II; HEPATITIS A TEST

Model Number	ANTI-HAV II
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-hav assay and elecsys anti-hav igm results for 1 patient sample on a cobas e 801 analytical unit.This medwatch will cover elecsys anti-hav.Refer to medwatch with a1 patient identifier (b)(6) for information on the elecsys anti-hav igm results.The initial anti-hav result was 0.21 coi, interpreted as positive.The initial anti-hav igm was 7.44 coi, interpreted as positive.The dates of testing were requested but not provided.The results were reported outside of the laboratory.The sample was sent for elisa testing.On (b)(6) 2023, the anti-hav igm elisa result was negative.On (b)(6) 2023, the anti-hav elisa result was negative.The manufacturer of the elisa tests was not provided.The analyzer serial number is (b)(6).
Additional Manufacturer Narrative
The patient sample was provided for investigation.The customer¿s positive a-hav ii and a-hav igm results could be reproduced.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined that the results reported by the customer could be reproduced and that the sample result is considered to be true reactive.The discrepancy of the results with elisa testing may be consistent with a patient with an early hepatitis a infection.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-HAV II
• Common Device Name: HEPATITIS A TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17046151
• Report Number: 1823260-2023-01809
• Device Sequence Number: 14713530
• Product Code: LOL
• UDI-Device Identifier: 07613336129715
• UDI-Public: 07613336129715
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K190428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2023

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: 07/31/2023
• Device Model Number: ANTI-HAV II
• Device Catalogue Number: 08086664190
• Device Lot Number: 62571702
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 06/16/2023; 07/17/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/13/2023; 07/25/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Female