MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HIV COMBI PT ELECSYS; HIV DETECTION TEST

Model Number HIVCOMBIPT

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).(b)(4).

Event Description

The initial reporter complained of questionable (b)(6) combi pt results for 1 patient tested on a cobas 6000 e 601 module.A (b)(6) result was reported outside the laboratory.The physician questioned the result because the patient was (b)(6).Refer to the attachment to the medwatch for all patient data.

Manufacturer Narrative

The customer returned samples for investigation.The samples are correctly non-reactive in hiv combi pt and false reactive in hiv duo (ag module).Due to the specificity as claimed in the corresponding method sheet of elecsys hiv duo, single false reactives can occur.The reagent performs within specification.

• Brand Name: HIV COMBI PT ELECSYS
• Type of Device: HIV DETECTION TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9157365
• MDR Text Key: 219220682
• Report Number: 1823260-2019-03575
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: BP160050/0
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HIVCOMBIPT
• Device Catalogue Number: 07914504190
• Device Lot Number: 378754
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1