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

Catalog Number	04660307190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer replaced the troponin reagent pack and performed a calibration.The field service engineer performed system checks and precision testing with acceptable results.After service, the customer performed qc and verified the qc results.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys troponin t stat assay results for three patients tested on a cobas 6000 e 601 module serial number (b)(4).The initial troponin results were reported outside the laboratory.The customer performed repeat testing with the samples on a different cobas 6000 e 601 module.At 19:45, patient 1's initial troponin result was 0.04 ng/ml.At 20:33, patient 1's repeat troponin result was 0.02 ng/ml.At 19:46, patient 2's initial troponin result was 0.04 ng/ml.At 20:33, patient 2's repeat troponin result was 0.01 ng/ml.At 20:33, patient 3's initial troponin result was 0.04 ng/ml.At 20:33, patient 3's repeat troponin result was 0.01 ng/ml.The customer determined the repeat troponin results were correct and corrected reports were provided.
Additional Manufacturer Narrative
The customer's calibration results were ok.The investigation confirmed the qc prior to the event was ok.After the event, the customer performed qc and the level 1 qc was out of range high.The investigation reviewed the system's alarm trace did not find any abnormalities.The customer's sample pre-analytics were requested but not provided.After service, no further issues were reported by the customer.The investigation determined the customer's actions of replacing the reagent resolved the issue.

• Brand Name: ELECSYS TROPONIN T STAT ASSAY
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12165318
• Report Number: 1823260-2021-02022
• Device Sequence Number: 3802603
• Product Code: MMI
• UDI-Device Identifier: 04015630921621
• UDI-Public: 04015630921621
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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: 493961
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/26/2021
• Supplement Date Received by Manufacturer: 06/26/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR