MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HIV COMBI PT; HIV DETECTION TEST

Catalog Number	08924180160
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e602 analyzer serial number is (b)(6).Controls were acceptable.Alarm trace data did not show any relevant alarms.Per product labeling: "the calculated values for anti-hiv and/or p24 antigen in a given specimen as determined by assays from different manufacturers can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay used.Values obtained with different assay methods cannot be used interchangeably.The reported antibody level and/or p24 antigen cannot be correlated to an endpoint titer." the investigation did not identify a product issue.The assay is performing as specified.
Event or Problem Description
The customer stated they received discrepant results for one patient sample tested with elecsys hiv combi pt on a cobas 8000 e 602 module.No questionable results were reported outside of the laboratory.The sample initially resulted in an hiv combi pt value of 0.2 coi (non-reactive).The sample was tested on an abbott point of care test strip for hiv 1/2 ag/ab combo and free hiv-1 p24; it was positive for the p24 antigen.The sample was repeated on the e 602 analyzer and the hiv combi pt value was negative.The sample was sent to another laboratory for confirmatory testing and the results for hiv-1 and hiv-2 were both negative.Hiv 1 and hiv 2 rna were undetected.

• Brand Name: ELECSYS HIV COMBI PT
• Common Device Name: HIV DETECTION 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23585685
• Report Number: 1823260-2025-04693
• Device Sequence Number: 9504982
• Product Code: MZF
• UDI-Device Identifier: 07613336170212
• UDI-Public: 07613336170212
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BP160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 08/31/2026
• Device Catalogue Number: 08924180160
• Device Lot Number: 84003401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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