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 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

The first e801 analyzer serial number is (b)(6).The second e801 analyzer serial number was not provided.The qc recovery data provided was acceptable.The patient sample was requested for investigation.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys hiv duo ver.2 results for 1 patient on two cobas e 801 analytical units.The patient had a pcr viral load test performed in the two weeks prior that was reactive with a result of > 1000000 copies/ml, log 7.0 and the patient received treatment from their doctor.The exact date of testing was not provided.On (b)(6) 2023, the patient had an initial hiv duo result of 0.526 coi, interpreted as non-reactive from a edta plasma sample when tested on the first e801 analyzer.The sample was repeated and the result was 0.530 coi, interpreted as non-reactive.The sample was repeated again on a second e801 analyzer and the hiv duo result was 0.537 coi, interpreted as non-reactive.A rapid visual hiv test was also performed on the sample and it gave a weakly positive result.On (b)(6) 2023, a heparinized plasma sample from the same collection was tested on the first e801 analyzer and the result was 0.803 coi, interpreted as non-reactive.

Manufacturer Narrative

The patient sample was received for investigation.The customer's results were confirmed during investigational testing.The investigation did not identify a product problem.

• 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: 18021639
• MDR Text Key: 326736333
• Report Number: 1823260-2023-03442
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (y/n): Y
• Reporter Country Code: TH
• 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: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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: 704865
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTI-HIV MEDICATION
• Patient Age: 18 YR
• Patient Sex: Male