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	11/08/2022
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 ii assay results for 1 patient sample on a cobas e 801 analytical unit.On (b)(6) 2022, the patient had anti-hav qualitative result of 0.008 c.O.I., interpreted as positive.On (b)(6) 2022 , the sample was re-centrifuged and repeated.The repeat anti-hav qualitative result was 0.00777 c.O.I., interpreted as positive.An anti-hav igm test was also performed on the sample and the result was 0.342 c.O.I., interpreted as negative.The sample was sent to another lab for elisa testing.The anti-hav igg and anti-hav igm results were both negative.It was confirmed that the patient had not recently received a hepatitis a vaccine.The positive anti-hav result was reported outside of the laboratory.The analyzer serial number is (b)(4).
Additional Manufacturer Narrative
The calibration and qc data provided were acceptable.The investigation did not identify a product problem.The root cause of the event could not be determined.
Additional Manufacturer Narrative
Patient samples were provided for investigation.The investigation was able to confirm the positive anti-hav result obtained at the customer site.Investigational thyroid testing was also performed which gave results indicating no interference with the anti-ru component of the reagent.The investigation is ongoing.

• 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: 15945121
• Report Number: 1823260-2022-03945
• Device Sequence Number: 6059629
• Product Code: LOL
• UDI-Device Identifier: 07613336129715
• UDI-Public: 07613336129715
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/04/2023

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: 62571701
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 01/09/2023; 04/14/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 02/07/2023; 05/04/2023
• 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 Age: 37 YR
• Patient Sex: Male