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

Catalog Number 05390095160

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/06/2022

Event Type  malfunction  

Event Description

The initial reporter questioned results for multiple patient samples tested for elecsys hiv combi pt (hiv combi) using a particular reagent pack on a cobas 8000 e 602 module.The customer stated the issue began a month ago after preventive maintenance was performed.The customer ran "a few" patient samples and all patient samples showed results of (b)(6) which is "very rare." the customer changed to a different reagent pack and repeated the patient samples.Upon repeating the patient samples, the result for 1 patient sample was discrepant.The initial result was (b)(6).The repeat result was (b)(6).The positive result was believed to be correct.The questionable result was not reported outside of the laboratory.The e602 module serial number was (b)(4).

Manufacturer Narrative

The customer was receiving reagent alarms.The customer ran qc on the new reagent pack and it was acceptable.The field service engineer (fse) could not reproduce the reagent alarms.The fse checked and cleaned multiple parts of the instrument and replaced the mixing paddle.Mechanism checks were successful.The customer ran qc and patient samples with no issues.

Manufacturer Narrative

The suspect medical device was updated.Applicable fields of sections d and g were updated.The hiv combi reagent lot number was 53282700 with an expiration date of 28-feb-2022.The field service engineer (fse) revisited the customer site and replaced the reagent probe and the liquid level detection (lld) board.Adjustments, air purges and mechanism checks were successful.The customer ran qc and samples with no issues.The investigation determined the service actions resolved the issue.

• 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): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13387410
• MDR Text Key: 291645050
• Report Number: 1823260-2022-00226
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 04015630942497
• UDI-Public: 04015630942497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05390095160
• Device Lot Number: 532827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 03/01/2022
• 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: 21 YR
• Patient Sex: Male