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

Catalog Number	08469865160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of a questionable result for 1 patient's plasma sample tested with the elecsys troponin t hs (tnths) gen 5 stat assay on cobas 6000 e601 immunoanalyzer serial number (b)(4).Initial result: 20 ng/l the questionable result was reported outside the laboratory and the physician mentioned that it did not match the patient's clinical picture.The sample was then repeated.Repeat result: 6 ng/l the repeat result deemed to be correct.Qc was acceptable on the day of the event.
Additional Manufacturer Narrative
The field service engineer found that the sample was contaminated.The sample in question (4th sample) in a tnths test series all being taken within 1 hr intervals.One of the results obtained was 19.4 ng/l.The technician respun (re-centrifuged) an aliquot of the sample and ran it again.The respun produced the correct result of 6 ng/l.The technician then reran the original sample without respun (centrifuge) and got the result of 20.3 ng/l.No problem with the analyzer was found.Precision studies were performed and they were within specifications.The investigation is ongoing.H3 other text : na.
Additional Manufacturer Narrative
The service actions performed resolved the issue.

• Brand Name: ELECSYS TROPONIN T GEN 5 STAT ASSAY
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16756191
• Report Number: 1823260-2023-01295
• Device Sequence Number: 18299379
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162895
• 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): 05/15/2023

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 08469865160
• Device Lot Number: 68811801
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/15/2023
• 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 Sex: Unknown