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 02/21/2024

Event Type  malfunction  

Event Description

The initial reporter received a questionable elecsys troponin t g5 stat result from one patient sample tested on the cobas 8000 - cobas e 602 module.The questionable troponin t 2-hour result was reported outside of the laboratory.The physician questioned the result as it did not match the patient's history (baseline result: 209 ng/l) prompting the rerun of the patient sample on another e 602 module.On (b)(6) 2024, the initial result from the module was 8 ng /l.On (b)(6) 2024, the repeat result from the other module was 199 ng/l.The repeat result was deemed correct.

Manufacturer Narrative

The serial number of the cobas 8000 - cobas e 602 module is (b)(6).The field service engineer (fse) inspected the module and found an issue in the module's channel 2, 4 mm of the sipper nozzle's teflon coating was missing which could cause fluid to stick to the tip causing the patient sample to be diluted when the nozzle enters the sample cup.He then replaced the sipper nozzle and verified the gear pump pressure.He performed a system volume check with acceptable results.He also verified all the alignments of the probes and nozzles and the condition of the pinch tubing.He verified the analyzer's performance by mechanical checks with successful results.The investigation is ongoing.

Manufacturer Narrative

Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The investigation reviewed the calibration signals performed on (b)(6) 2024.The investigation reviewed the qc recovery; the qc recovery was within -2 standard deviations; there was no indication of a performance issue with the reagent.The investigation reviewed the alarm trace; no issues were noted.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• 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: 18901889
• MDR Text Key: 337630924
• Report Number: 1823260-2024-00754
• 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: 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: 04/11/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 74311200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• 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: 67 YR
• Patient Sex: Female