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

Model Number	E411 DISK
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received discrepant results for five patient samples tested with the elecsys troponin t hs stat assay on a cobas e 411 analyzer (disk system).Patient sample 1: the sample initially resulted in a troponin t hs stat value of 23.86 pg/ml.The sample was repeated three times, resulting in values of 11.19 pg/ml, 35.52 pg/ml and 37.43 pg/ml.The result deemed correct was 8.3 ng/l.Patient sample 2: the sample initially resulted in a troponin t hs stat value of 18.6 pg/ml.The sample was repeated three times, resulting in values of 27.9 pg/ml, 12.9 pg/ml, and 19.6 pg/ml.It is unknown which result was deemed correct.Patient sample 3: the sample initially resulted in a troponin t hs stat value of 27.85 pg/ml and repeated as 12.91 pg/ml.The result deemed correct was 78.8 ng/l patient 4: the sample initially resulted in a troponin t hs stat value of 16.62 pg/ml.The result deemed correct was 8.6 ng/l.Patient 5: the sample initially resulted in a troponin t hs stat value of 12.25 pg/ml and repeated as 21.86 pg/ml.The result deemed correct was 12.5 ng/l.The questionable results were reported outside of the laboratory.It was asked but it is unknown if the results that were deemed correct were obtained on the same cobas e 411 analyzer.It was asked but it is unknown if patients 1 and 5 are the same person.The troponin t hs stat reagent lot was 596381 with an expiration date of 31-mar-2023.
Additional Manufacturer Narrative
It was confirmed that patient samples 1 and 5 derive from the same patient.The results deemed correct were obtained on a second e 411 in a different laboratory.
Additional Manufacturer Narrative
Upon review of the alarm trace, two measuring cell-related alarms were observed.During a service visit by the field service engineer, several actions were performed including verification of the storage conditions of the reagents.It was determined that the refrigeration of the reagents was not in accordance with the recommended storage conditions.Per product labeling: "storage and stability, store at 2 8 °c." the investigation could not identify a product problem.The issue is consistent with incorrect storage conditions.
Additional Manufacturer Narrative
Medwatch fields d1, d2, d2b, d4, g1, and g4 have been updated.

• 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: 16454133
• Report Number: 1823260-2023-00601
• Device Sequence Number: 3466723
• Product Code: MMI
• UDI-Device Identifier: 04015630921621
• UDI-Public: 04015630921621
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2023
• 2 Devices were Involved in the Event: 1 2

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: 03/31/2023
• Device Model Number: E411 DISK
• Device Catalogue Number: 04660307190
• Device Lot Number: 596381
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 03/02/2023; 04/12/2023; 04/12/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/28/2023; 05/02/2023; 05/05/2023
• 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: 63 YR
• Patient Sex: Female