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 03/14/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys troponin t gen 5 stat assay on cobas 6000 e601 module serial number (b)(4).The sample initially resulted in a troponin t value of 8.00 ng/l and this value was reported outside of the laboratory to the physician.A second sample collected from the patient had an extremely high troponin t result, so the complained sample was repeated, resulting in a value of 141 ng/l.The repeat value was deemed correct.

Manufacturer Narrative

Na.

Manufacturer Narrative

For the last calibration performed on (b)(6) 2023, signals were within expectations.Controls were within range on the day of the event.The field service engineer determined that the sample potentially had a bubble that the system did not detect due to bubble detection being turned off.The engineer activated bubble detection on the analyzer.Performance testing was run and recovered within specifications.Alignments were checked.Precision studies were performed.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16706371
• MDR Text Key: 312947340
• Report Number: 1823260-2023-01142
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162895
• 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: 04/19/2023

1 Device was Involved in the Event

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 08469865160
• Device Lot Number: 68811801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 04/19/2023
• 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
• Patient Age: 63 YR
• Patient Sex: Male