MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HIV DUO ELECSYS E2G 300 V2; HIV DETECTION TEST

Catalog Number 08836973190

Device Problem False Positive Result (1227)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

The patient samples were provided for investigation.Patient samples 1 and 3 were found to be non-reactive with the hiv duo assay.The reactive value for patient sample 2 could be duplicated.All three patient samples were positive for sars-c0v-2 antibodies.Due to low sample volume, additional testing could not be performed.This event occurred in (b)(6).Medwatch field udi number: (b)(4).

Event Description

The initial reporter stated they received false positive results for three patient samples tested with the elecsys hiv duo on cobas 8000 e 801 module analyzers.No incorrect results were reported outside of the laboratory.The reporter alleges there is cross-reactivity between covid-19 positive patients and the assay.Samples 1 and 2 were tested using e 801 analyzer serial number (b)(4) and the third sample was tested using e 801 analyzer serial number (b)(4).All three patients went to the hospital for covid pneumopathy, with diabetes and high blood pressure.All three patients are covid-19 positive.

Manufacturer Narrative

Based on the claimed assay specificity, single false positives can occur.The reagent performed within specifications.

• Brand Name: HIV DUO ELECSYS E2G 300 V2
• Type of Device: HIV DETECTION TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11759377
• MDR Text Key: 248490951
• Report Number: 1823260-2021-01301
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: BP190403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• 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: 482038
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1