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

Catalog Number	08086664190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about questionable positive results for 1 patient's serum/plasma sample tested with elecsys anti-hav g2 (anti-hav ii) assay on a cobas e801 immunoassay analyzer.On (b)(6) 2023: initial result: 0.674 coi (positive).On (b)(6) 2023, a new sample was drawn and tested.Result: 1.020 coi (negative).Rerun result: 1.060 coi (negative).The results were not consistent with the patient's previous results.The repeat result of the original sample from (b)(6) 2023 was 1.030 coi (negative).
Additional Manufacturer Narrative
The cobas e801 module serial number was (b)(6).Qc and calibration were acceptable.The alarm trace showed multiple sample foam detection alarms on the day of the event.The investigation is ongoing.
Additional Manufacturer Narrative
Pre-analytical data, alarm trace, and images were provided for investigation.An instrument check was done on (b)(6)2023 and the instrument was performing within specifications.The investigation of the sample images identified 3 different issues where the samples contained air bubbles, appeared to be turbid (fibrin clots) and contained a film/particles.The active gripper wheels appeared dusty.The investigation did not identify a product problem.The elecsys anti-hav ii assay performs within specifications.The cause of the event was due to pre-analytical issues (the samples contained air bubbles, appeared to be turbid/fibrin clots, and contained a film/particles) at the customer's site.Preanalytics are within the customer's responsibility.

• 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: 18485661
• Report Number: 1823260-2024-00109
• Device Sequence Number: 13015941
• Product Code: LOL
• UDI-Device Identifier: 07613336129715
• UDI-Public: 07613336129715
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 02/16/2024

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: 08/31/2024
• Device Catalogue Number: 08086664190
• Device Lot Number: 73012701
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/16/2024
• 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