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 06/12/2023

Event Type  malfunction  

Event Description

There was an allegation of a discrepant negative elecsys hiv duo result for one patient sample from a cobas e 801 module serial number (b)(6).On (b)(6), 2023, the following results were obtained: the initial result from the hiv duo was 0.852 coi, non-reactive (hivag 0.186 coi and ahiv 0.831 coi).The repeat result from the hiv duo was 0.811 coi, non-reactive (hivag 0.186 coi and ahiv 0.789 coi).The repeat result from the hiv duo on a second e 801 module was 0.925, non-reactive.The result from the hiv combipt on an e 601 module was 1.65 coi, reactive.The result from the alinity hiv ag/ab method was 4.87 s/co, reactive.The result from the architect hiv ag/ab method was 5.08 s/co, reactive.The result from the hiv ab vidas method was 0.52 (cutoff 0.25), reactive.The initial result from the hiv pcr (cobas mpx test) was ct 37.13, reactive and repeated as ct 37.13, reactive.The result from the hiv 1/2 geenius (immunochromatography test) was reactive (gp140 present).On (b)(6), 2023, the following results were obtained from a new sample, collected from the same patient: the result from the hiv duo was 2.09 coi, reactive (hivag 0.173 coi and ahiv 2.08 coi).The result from the alinity hiv ag/ab method was 4.47 s/co, reactive.The result from the hiv pcr (cobas mpx test) method was ct 36.94, reactive.The result from the hiv 1/2 geenius (pcr-immunochromatography test) was reactive (gp140 present).On (b)(6), 2023, the initial sample was repeated on a different cobas e 801 by using reagent lot 631252: the result from the hiv duo was 0.925 coi, non-reactive.On (b)(6), 2023, recalibration was performed and the initial sample was repeated: the result from the hiv duo was 0.829 coi, non-reactive.No questionable results were reported outside of the laboratory.

Manufacturer Narrative

The samples were requested for investigation.

Manufacturer Narrative

Calibration signals were acceptable.Quality controls were within specifications.Two patient samples were received for investigation and retested.The sample draw from 12-jun-2023 was found to be non-reactive and the sample draw from 14-jun-2023 was found to be reactive in the elecsys hiv duo assay.The samples were further tested with the biorad new lav blot 1 and the inno-lia hiv i/ii score, where the sample from (b)(6) 2023 had an indeterminate and negative result and the sample from (b)(6) 2023 had both times an indeterminate result.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.The investigation did not identify a product problem.Per product labeling: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings." "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.".

• 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: 17328537
• MDR Text Key: 319313938
• Report Number: 1823260-2023-02257
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (y/n): N
• 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: 01/08/2024

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 Expiration Date: 04/30/2024
• Device Catalogue Number: 08836973190
• Device Lot Number: 65025901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/08/2024
• 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