MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TROPONIN T STAT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number	04660307190
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys troponin t stat assay on cobas 6000 e601 module serial number (b)(4).The sample initially resulted in a troponin t value of 80.56 ng/ml and this value was reported outside of the laboratory.A second sample collected from the patient resulted in a troponin t value of 9.10 ng/ml, so the doctor questioned the initial value from the complained sample.The sample was repeated twice on the same analyzer, resulting in troponin t values of 14.89 ng/ml and 17.37 ng/ml.The 14.89 ng/ml value was deemed correct.The sample was also repeated on a second e601 analyzer (unknown serial number), resulting in a troponin t value of 18.66 ng/ml.
Additional Manufacturer Narrative
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Additional Manufacturer Narrative
The customer stated that controls recovered within range and there were no calibration issues.Rack adapters required for 13 mm.Diameter tubes were not used.The sample centrifugation may have been shorter and the speed may have been higher than recommended by the tube manufacturer.Upon review of the alarm trace, an incubator bath water level sensor alarm, a low reagent level alarm, and short system reagent alarms were observed.The field service engineer determined the issue was related to sample integrity.The system worked within specifications.Seals, the sample probe, and sipper nozzles were replaced.Performance testing passed.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.

• Brand Name: TROPONIN T STAT
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• 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: 16746183
• Report Number: 1823260-2023-01273
• Device Sequence Number: 19649523
• Product Code: MMI
• UDI-Device Identifier: 04015630921621
• UDI-Public: 04015630921621
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04660307190
• Device Lot Number: 688118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female