MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV IGM; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Catalog Number	07026773190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e801 analytical unit serial number was (b)(6).The samples were centrifuged at a high speed before being tested.The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable results not matching the patients' clinical diagnosis for 2 patients when tested with elecsys anti-hav igm assay on a cobas e801 immunoassay analyzer.Sample 1 (patient 1): initial result: 1.09 coi.1st repeat result: 1.10 coi.2nd repeat result: 1.09 coi (tested with the same lot and different pack number).3rd repeat result: 1.06 coi (tested with the same lot and different pack number).Sample 2 (patient 2): initial result: 1.50 coi.1st repeat result: 1.48 coi.2nd repeat result: 1.49 coi (tested with the same lot and different pack number).3rd repeat result: 1.50 coi (tested with the same lot and different pack number).Both samples' results were interpreted as false positive.
Additional Manufacturer Narrative
No sample material was available for investigation.No information about medical history was provided.A general reagent issue could be excluded.The investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-HAV IGM
• Common Device Name: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• 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: 19053467
• Report Number: 1823260-2024-01053
• Device Sequence Number: 12530094
• Product Code: LOL
• UDI-Device Identifier: 04015630939855
• UDI-Public: 04015630939855
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K093955
• 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): 04/22/2024

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: 06/30/2024
• Device Catalogue Number: 07026773190
• Device Lot Number: 74541001
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 04/22/2024
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian