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

Catalog Number	08924180160
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys hiv combi pt results from the cobas e 602 module.The initial result was 1.4 coi (reactive).The sample was repeated twice, with a result of >5000 coi (reactive) each time.The sample was repeated on another analyzer at the site, and the result was >1.0 coi (reactive).No questionable result was reported outside of the laboratory.The repeat result was believed to be correct.
Additional Manufacturer Narrative
The cobas e 602 module serial number was (b)(6).The field service engineer checked the analyzer and determined the event was consistent with an issue with the sample.He performed water and gear pump adjustments, ran mechanism checks, ran measuring cell preparations, and performed a system volume check.He ran performance testing with passing results.The investigation is ongoing.
Additional Manufacturer Narrative
No calibration issues were found, and the qc results were within the customer's established ranges before sample measurement.Relevant alarms for "procell /cleancell short" and "preclean short" were observed in the analyzer alarm trace.The investigation was unable to determine a specific root cause.There was no product problem identified.

• 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: 22816285
• Report Number: 1823260-2025-02513
• Device Sequence Number: 9014127
• Product Code: MZF
• UDI-Device Identifier: 07613336170212
• UDI-Public: 07613336170212
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 11/26/2025

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 Catalogue Number: 08924180160
• Device Lot Number: 840034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/27/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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