MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T GEN 5 STAT ASSAY; TROPONIN SUBUNIT IMMUNOASSAY METHOD

Catalog Number 08469865160

Device Problem Low Test Results (2458)

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

Event Date 09/17/2023

Event Type  malfunction  

Event Description

We received an allegation about discrepant results for 1 patient's plasma sample tested with elecsys troponin t g5 stat assay on a cobas e411 immunoassay analyzer when compared to a different cobas e411 immunoassay analyzer.Initial result: 9 ng/l.Repeat result: 11 ng/l.The repeat result was deemed to be correct.

Manufacturer Narrative

The cobas e411 rack serial number was (b)(6).On the day of the event, there were issues with qc so the customer calibrated and ran the qc again and it passed.By the end of the day, the customer ran qc and it failed so they retested the patients' samples for that day.The customer uses a 3rd party qc.The investigation is ongoing.

Manufacturer Narrative

The last calibration was performed on (b)(6) 2023 and it was acceptable.Qc recovery had results outside the acceptable range.The alarm trace showed no abnormalities.The cause was consistent with a blocked flow path.The field service engineer (fse) ran a fishing line through the sipper flow path.He also ran liquid flow cleaning and checked all adjustments.Precision studies were performed and they were within specifications.The customer performed calibration and qc and they were acceptable.The fse did a performance check and the instrument was performing within specifications.The service actions done by the fse resolved the issue.No further issues were reported afterward.

• Brand Name: ELECSYS TROPONIN T GEN 5 STAT ASSAY
• Type of Device: TROPONIN SUBUNIT IMMUNOASSAY METHOD
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17876993
• MDR Text Key: 324993801
• Report Number: 1823260-2023-03187
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K961481
• 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: 11/21/2023
• 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: 08469865160
• Device Lot Number: 72613501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/21/2023
• 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
• Treatment: COREG; LAVOXAL; LIPITOR; LISINOPRIL; METFORMIN
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 90 KG