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	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 e601 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's sample tested with elecsys anti-hav ii (anti-hav g2) assay on a cobas 6000 e601 immunoassay analyzer.Initial result: 0.782 coi.1st rerun result: 0.764 coi.Since the results did not match the patient's clinical history, the customer performed a liquid flow cleaning on the instrument, re-calibrated, and reran qc.The patient's sample was then rerun.2nd rerun result: 1.18 coi.The 2nd rerun result was deemed to be correct as it matched the patient's clinical picture.
Additional Manufacturer Narrative
Qc was out of range on the day of the event.After doing test re-calibration, the qc was within range.The cause was unclear and the customer mentioned the bad quality of the external water source.The field service engineer performed decontamination of the instrument.He also did preventive maintenance.The customer was advised to do the daily maintenance, check the conductivity of the water, and install another water filtration system to prevent the issue from happening again.The service actions (decontaminating the instrument) resolved the issue.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17939730
• Report Number: 1823260-2023-03306
• Device Sequence Number: 12366291
• Product Code: LOL
• UDI-Device Identifier: 07613336129722
• UDI-Public: 07613336129722
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• 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): 11/13/2023

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 Catalogue Number: 08086630190
• Device Lot Number: 69555601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/13/2023
• 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