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

Catalog Number 08469865160

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

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

Event Date 03/17/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas e411 rack is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys troponin t g5 stat results from seven patient samples tested on the cobas 6000 e601 module.The qc was out-of-range (high) on 17-mar-2024 and 18-mar-2024 prompting the rerun of the patient samples.The reporter was able to provide one patient sample with discrepant results: the questionable result was reported outside of the laboratory.The initial result was 15 pg/ml.The first repeat result was 153 pg/ml.The repeat result was deemed correct.

Manufacturer Narrative

Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The investigation reviewed the last calibration performed on (b)(6) 2024; the results were within specifications.The customer stated that the qc was out of range (high) on (b)(6) 2024 and (b)(6) 2024.The investigation reviewed the alarm trace; no issues were noted.On the field service engineer (fse)'s initial service visit, he inspected the analyzer and could not establish a cause for the event.He then performed an instrument check; the results were out of specifications.He replaced the measuring cells and the sample and reagent probes.He again performed an instrument check which revealed a sipper pipetting issue.On the fse's follow-up visit, he noted that the acrylic distribution block had hairline cracks causing air bubbles on the syringe and tubing.He then replaced the sipper nozzle and tubing from the sipper to the measuring cells.He noticed air bubbles in the lines.He then replaced the syringe assembly and acrylic block and performed minor adjustments.He again performed instrument checks and precision checks with successful results.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: 19051568
• MDR Text Key: 340456329
• Report Number: 1823260-2024-01051
• 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: 04/24/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• 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: 743112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• 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: 50 YR
• Patient Sex: Female