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 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The e411 rack analyzer serial number is (b)(4).Qc results were within specification.The sample was requested for investigation but could not be provided.Based on the calibration and qc data provided, the assay performs within specification.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of (b)(6) results for 1 patient tested for elecsys hiv combi pt (hiv combi pt) on a cobas e411 rack analyzer.The patient had initially been tested at a different laboratory using the abbott rapid test strip and the khb colloidal gold method and received "(b)(6)" results.The actual results were not provided.The sample was sent to the customer site for confirmation.The result from the e411 instrument was (b)(6).The repeat from the e411 instrument was (b)(6).The roche results were reported outside of the laboratory as "inconclusive." the customer repeated the sample on a cobas e801 with an ahiv of (b)(6) and an hivag of (b)(6).The customer also repeated the sample by the architect method and the hiv result was (b)(6).There was no allegation that an adverse event occurred.

• 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: 8817947
• MDR Text Key: 152061339
• Report Number: 1823260-2019-02670
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• 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: 37875401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2019
• 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