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

Model Number HIV COMBI

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

The initial reporter complained of a questionable negative result for 1 patient sample tested for elecsys hiv combi pt (hiv combi) on a cobas 6000 e 601 module.The initial result was 0.125 coi (negative).This result was reported outside of the laboratory.A positive result was expected as the patient has been diagnosed with hiv.On (b)(6) 2022 the repeat result was 341.6 coi (positive).The e601 module serial number was (b)(4).

Manufacturer Narrative

On (b)(6) 2022 the field service engineer (fse) visited the customer site and found no instrument issues.The investigation did not identify a product problem.The specific cause of the event could not be determined.As no instrument issues were identified, the investigation determined the event was consistent with either a handling issue of the reagent pack or an issue with the patient sample (foam on the sample).

• 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: 14252396
• MDR Text Key: 299456412
• Report Number: 1823260-2022-01226
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BP160050
• 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: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: HIV COMBI
• Device Catalogue Number: 05390095190
• Device Lot Number: 56156700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• 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
• Patient Age: 81 YR
• Patient Sex: Male