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 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

The last calibration performed on e 601 serial number (b)(4) was (b)(6) 2019 had signals within expected ranges.Quality control data was within expected ranges, including the date of the event.The investigation could not identify a product problem.The cause of the event could not be determined.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys hiv combi pt on two cobas 8000 e 602 module analyzers.No incorrect results were reported outside of the laboratory.The sample initially resulted with an hiv value of 0.156 coi (non-reactive) when tested on the first e 602 analyzer.The sample was repeated on a second e 602 analyzer, resulting with a value of 0.163 coi (non-reactive).The sample was repeated twice on a siemens centaur analyzer, each time resulting with a value of > 12.000 index (reactive).A rapid test performed on the patient resulted with a positive hiv value.On (b)(6) 2019, the patient sample was tested using the western blot riba method and the hiv result was negative.The serial number of the first e 601 analyzer is (b)(4) and the serial number of the second e 601 analyzer is (b)(4).

• 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: 8983757
• MDR Text Key: 207327510
• Report Number: 1823260-2019-03261
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• 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: 378754
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2019
• 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