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

Model Number	ANTI-HAV II
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 15 patient samples tested for elecsys anti-hav ii (anti-hav ii) between different reagent lots on a cobas e 801 analytical unit.Patients who previously had reactive results are now non-reactive.Refer to the attached data for the patient results.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).The customer provided 3 reagent lot numbers: 625717, 591806, and 695558.It is not clear which reagent was used for which result.The expiration dates were not provided.The investigation is ongoing.H3 other text : na.
Additional Manufacturer Narrative
Section d4, expiration date was updated.The expiration date for reagent lot 625717 was 31-jul-2023.The expiration date for reagent lot 591806 was 31-may-2023.The expiration date for reagent lot 695558 was 31-mar-2024.Calibration data for reagent lots 625717 and 695558 was acceptable.Calibration for reagent lot 591806 showed failing alarms.It is not known if calibration was acceptable during the time the samples were measured.No qc data for reagent lot 591806 was provided.No sample material was submitted for investigation.Lot-to-lot comparison studies were performed during the investigation and the results were within the specifications.The reagent performs within specification.The investigation did not identify a product problem.

• 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: 17362981
• Report Number: 1823260-2023-02369
• Device Sequence Number: 6079750
• Product Code: LOL
• UDI-Device Identifier: 07613336129715
• UDI-Public: 07613336129715
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/29/2023

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: 03/31/2024
• Device Model Number: ANTI-HAV II
• Device Catalogue Number: 08086664190
• Device Lot Number: 695558, 625717, 591806
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/29/2023
• 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