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

Catalog Number	08086630190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with the elecsys anti-hav ii assay on a cobas 6000 core unit, serial number (b)(4).Patient sample 1: on (b)(6) 2023, the sample had an anti-hav ii result of 0.867 (reactive).The result was reported outside of the laboratory and questioned by the physician.At an unknown date, the sample was measured with the architect i1000sr method, resulting in a non-reactive anti-hav igg result.
Additional Manufacturer Narrative
Calibration and quality control results do not indicate an issue.Further investigation was not possible as the sample was not available.The investigation could not identify a product problem.The 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: 16700324
• Report Number: 1823260-2023-01124
• Device Sequence Number: 17063120
• Product Code: LOL
• UDI-Device Identifier: 07613336129722
• UDI-Public: 07613336129722
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K190428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 05/05/2023

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 Catalogue Number: 08086630190
• Device Lot Number: 625986
• 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: 03/11/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/05/2023
• 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