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

Model Number HIV COMBI

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

The patient samples could not be provided for further investigation.Without the patient samples, the cause of the event could not be determined.The investigation did not identify a product problem.The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable elecsys hiv combi pt results for 2 patients tested on a cobas e 411 immunoassay analyzer compared to different rapid result tests.The rapid reagents were from oncoprobe and rightsign.For patient 1: the cobas e411 hiv combi pt result was (b)(6) while the rapid hiv method results were both (b)(6).For patient 2: the cobas e411 hiv combi pt result was (b)(6).The rapid hiv method results were both (b)(6).Patient 2 is a (b)(6) male with a date of birth that was requested but not provided.For patient 2, the clinical pathologist determined that the interpretation of the results was "indeterminate." on (b)(6) 2019 patient 2 sample was tested on a cobas 6000 e601 and had an hiv result of (b)(6).The cobas e411 serial number was (b)(4).The results in question were reported outside of the laboratory.

• Brand Name: ELECSYS HIV COMBI PT
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 9083648
• MDR Text Key: 219124652
• Report Number: 1823260-2019-03378
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: BP160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: HIV COMBI
• Device Catalogue Number: 05390095190
• Device Lot Number: 37875403
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR