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

Catalog Number 08836973190

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e 801 immunoanalyzer serial number was (b)(6).Calibration and qc were performed on the days of the testing and they were all within the specified ranges.The investigation is ongoing.

Event Description

We received an allegation about a questionable negative results for 1 patient's serum sample tested with elecsys hiv duo assay on a cobas e801 immonoassay analyzer when compared to nucleic acid (nat) screening test.The sample was from a donor.Sample 1: on (b)(6) 2023: hiv duo result: 0.308 coi (non-reactive) hiv antigen (hivag) result: 0.290 coi anti-hiv (ahiv) result: 0.104 coi.Sample 2: a new sample was drawn and tested on (b)(6) 2023: hiv duo result: 0.438 coi (non-reactive) hiv antigen (hivag) result: 0.426 coi anti-hiv (ahiv) result: 0.103 coi.On (b)(6) 2023: results of nat testing (pool): reactive in hiv results of nat testing (single sample): reactive in hiv.

Manufacturer Narrative

Taking all results into account, the cause of the event was consistent with that the patient sample is very likely from an early seroconversion phase, which was detected by pcr only.Early hiv seroconversion phase, which could be detected by pcr only.The investigation did not identify a product problem.A negative test result does not completely rule out the possibility of an infection with hiv.Serum or plasma samples from the very early phase (or the late phase) of hiv infection can occasionally yield negative findings.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.

• Brand Name: ELECSYS HIV DUO
• Type of Device: 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17612442
• MDR Text Key: 321848640
• Report Number: 1823260-2023-02755
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: BP190403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08836973190
• Device Lot Number: 69030301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 67 KG