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	01/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned ongoing positive results for 3 patient samples tested for elecsys anti-hav igm (anti-hav igm) on a cobas e 801 analytical unit.The date of event is an approximation.Only the year of testing was provided.For patient 1: in 2020, the patient had a result of 1.2 coi (positive).In 2022, the patient had a result of 1.1 coi (positive).For patient 2: in 2020, the patient had a result of 1.7 coi (positive).In 2022, the patient had a result of 1.5 coi (positive).In 2023, the patient had a result of 1.7 coi (positive).On (b)(6) 2023 the sample was repeated with a result of 1.49 coi (positive).For patient 3: in 2021, the patient had a result of 2.9 coi (positive).In 2022, the patient had a result of 3.5 coi (positive).In 2023, the patient had a result of 3.0 coi (positive).A sample from patient 3 was also sent for testing by the alinity method and the result was positive.The specific result was not provided.
Additional Manufacturer Narrative
Sample material was requested for investigation.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6) a specific root cause could not be identified as insufficient patient sample volume was received for investigation.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: 17896501
• Report Number: 1823260-2023-03227
• Device Sequence Number: 17921990
• Product Code: LOL
• UDI-Device Identifier: 04015630939855
• UDI-Public: 04015630939855
• Combination Product (Y/N): Y
• Initial Reporter Country: TH
• 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): 11/02/2023

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: 07026773190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/02/2023
• 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