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	04/19/2023
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 results for 1 patient on a cobas e 801 analytical unit.On (b)(6) 2023, the anti-hav result was 1.050 coi, interpreted as negative, and an a-hav igm result of 0.284 coi, interpreted as negative.The sample was repeated and the repeat anti-hav result was 1.11 coi.On (b)(6) 2023, the anti-hav result was 0.781 coi, interpreted as positive, and an a-hav igm result of 0.358 coi, interpreted as negative.The sample was repeated and the repeat anti-hav result was 0.84 coi.On (b)(6) 2023, the anti-hav result was 0.979 coi, interpreted as positive, and an a-hav igm result of 0.411 coi, interpreted as negative.It is unknown if any questionable results were reported outside of the laboratory.The analyzer serial number is (b)(6).
Additional Manufacturer Narrative
Section d4, expiration date was updated.The patient samples were provided for investigation.The investigation did not identify any interfering factors in the patient sample.The customer's results of the first two samples, but not the third sample, could be reproduced.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: 16987492
• Report Number: 1823260-2023-01725
• Device Sequence Number: 6772157
• 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
• Report Date (Section B): 07/10/2023

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: 625717
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/10/2023
• 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: Unknown