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

Catalog Number	08469865160
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 601 analyzer is (b)(6).The field service engineer cleaned the inside of the sipper probes and pre-wash system tubing.Probes were externally cleaned.Maintenance actions, including a probe washes, mixer rinsing, pre-wash system rinsing, reagent priming, and air purges were performed.Measuring cell preparation maintenance was performed.A system volume check, photomultiplier tube high voltage adjustment, and blank cell calibration were performed.Performance testing was run.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys troponin t gen 5 stat on a cobas 6000 e601 module.The sample initially resulted in a troponin t value of 11.12 ng/l.The patient's nurse asked for a repeat of the sample since the value did not agree with the patient's clinical status.The sample was repeated, resulting in a value of 115.2 ng/l with a data flag.The repeat value was deemed correct.
Additional Manufacturer Narrative
The investigation included a review of the data set provided by the customer: the qc results were within the specified ranges.There was no indication of a performance issue with the reagent.The alarm trace contained "abnormal probe sucking" and "sample short" errors.These are indicators of possible poor sample quality.A general reagent problem was not detected because the qc before the event was within ranges, and isolated non-reproducible results do not represent a general malfunction of the assay.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TROPONIN T GEN 5 STAT
• Common Device Name: TROPONIN SUBUNIT IMMUNOASSAY METHOD
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24177349
• Report Number: 1823260-2026-00272
• Device Sequence Number: 9979322
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201441
• 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): 03/19/2026

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 08469865160
• Device Lot Number: 86959401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown