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 05/08/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys hiv duo results for 1 patient sample on a cobas e 801 analytical unit.The initial hiv duo result was 0.191 coi, interpreted as non-reactive.The sample was repeated and the result was 0.236 coi, interpreted as non-reactive.The patient had an elecsys hiv combi pt test performed on an e601 analyzer and the result was 438.9 coi, interpreted as reactive.A pcr test was performed on the patient sample and the result was negative.A western blot test was not performed as there was no sample left.The negative pcr test result was reported outside of the laboratory.The e801 analyzer serial number (b)(6) the e601 analyzer serial number was requested but not provided.

Manufacturer Narrative

The calibration and qc data provided were acceptable.The alarm trace did not contain a conspicuous event.There was no patient sample left for investigation.The investigation did not identify a product problem.The root cause of the event could not be determined.H3 other text : na.

• 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: 17062013
• MDR Text Key: 316770849
• Report Number: 1823260-2023-01851
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 07613336166949
• UDI-Public: 07613336166949
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 06/05/2023

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 Expiration Date: 06/30/2023
• Device Catalogue Number: 08836973190
• Device Lot Number: 62274901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/05/2023
• 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