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

Model Number	TNT G5 STAT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample id (b)(6) was also sent to another laboratory for polyethylene glycol (peg) precipitation.After precipitation, the sample was sent back to the customer laboratory and tested on the e 602 analyzer, resulting in the following troponin t values: "peg" = 975.9 ng/l, "pbs" = 763.5 ng/l.When asked what "peg" and "pbs" stood for, the customer stated that these are two different ways the sample was analyzed and one was probably a control for the precipitation.Sample id (b)(6) was tested for human anti-mouse antibodies and the result was 6 ng/ml.
Event or Problem Description
The initial reporter alleged they received questionable results for five samples collected from the same patient and tested with the elecsys troponin t gen.5 stat assay on a cobas 8000 e 602 module (serial number (b).The sample results were reported outside of the laboratory and did not agree with the clinical picture of the patient.All samples collected from the patient allegedly resulted in troponin t values around 1000 ng/l.The customer alleged the results should be negative according to the clinical picture of the patient.The customer reported that dilution studies ruled out the possibility of heterophilic antibody interference.The customer believes the issue may be related to macro troponin t interference based on the study in attachment 1.Refer to attachment 2 for all patient data.Dilution studies to rule out the possibility of heterophilic antibody interference were performed with sample id (b)(6).
Additional Manufacturer Narrative
Four of the patient samples were provided for investigation.The results obtained during investigations differed from the results reported by the customer.Three of the four samples showed a lower result between 564.8 ng/l and 697.4.Only one sample had a result of 864.6 ng/l, which is near the customer reported results.The tni result for all samples were below measuring range.Based on serum fractionation results, the measured troponin t value in the complained samples was determined to be a true positive value.The presence of an interfering factor was not shown.A general reagent issue can be excluded.
Additional Manufacturer Narrative
Component, evaluation method, evaluation result, and evaluation conclusion codes have been updated.

• 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
• 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: 14949978
• Report Number: 1823260-2022-01986
• Device Sequence Number: 11907913
• Product Code: MMI
• UDI-Device Identifier: 04015630942695
• UDI-Public: 04015630942695
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051752
• 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,Followup
• Report Date (Section B): 10/21/2022

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: 02/28/2023
• Device Model Number: TNT G5 STAT
• Device Catalogue Number: 07398000160
• Device Lot Number: 57731600
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 09/27/2022; 10/04/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 10/20/2022; 10/21/2022
• 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