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

Catalog Number 08836973190

Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter stated they received a false negative result for one patient sample tested with the elecsys hiv duo assay on a cobas e 801 module serial number (b)(4).The initial main result was non reactive.A numeric result was not provided.This result was reported outside of the laboratory to the doctor and questioned by the patient as they were exposed to hiv.The repeated main result on another e801 was 0.418 coi (non reactive).The patient questioned this result as well.

Manufacturer Narrative

The investigation found the calibration and qc recovery were acceptable.There was no indication for a performance issue of the reagent or the instrument on both e801 modules.As the customer was unable to provide further information, a definite root cause analysis is not possible.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 12387685
• MDR Text Key: 272896775
• Report Number: 1823260-2021-02528
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (y/n): N
• PMA/PMN Number: BP190403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

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: 518974
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1