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 02/22/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received questionable negative results for one patient sample tested with elecsys hiv duo on two cobas e 801 modules.It was asked, but it is not known if any questionable results were reported outside of the laboratory.The patient is known hiv positive as of (b)(6) 2022.The patient sample was initially tested with the abbott alinity hiv method, resulting in a value of 68.26 (positive).No units of measure were provided.The sample was then repeated on the first e 801 analyzer (serial number 18g3-03), resulting in an hiv duo value of 0.605 coi (non-reactive).The sample was also repeated on a second e 801 analyzer (serial number unknown), resulting in an hiv duo value of 0.66 coi (non-reactive).The sample was repeated using elfa methodology, resulting in a value of 0.80 (positive).No units of measure were provided for this test.

Manufacturer Narrative

Calibration data were within expected ranges.The patient sample was requested for investigation, but could not be provided.The investigation could not identify a product problem.The cause of the event could not be determined.Per product labeling: "repeatedly reactive samples must be confirmed according to cdc recommended confirmatory algorithms.The subresults for either hivag or ahiv can be used as an aid in the selection of the confirmation algorithm for reactive samples.".

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16531796
• MDR Text Key: 311333866
• Report Number: 1823260-2023-00793
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/10/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 08836973190
• Device Lot Number: 59629402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 04/10/2023
• 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: 12 MO
• Patient Sex: Male