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

Catalog Number	04660307190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys troponin t stat assay results not corresponding to the clinical picture for two samples from one patient tested on the cobas 8000 - cobas e 602 module with serial number (b)(4).The initial result was reported outside of the laboratory.Upon receiving the result, the clinician asked the patient to go to the emergency room.At the emergency room, the patient was tested for troponin i using an abbott architect analyzer.A new sample was obtained from the patient for the troponin t and troponin i assays.The reporter recalibrated the troponin t assay and rerun the sample.This sample was also sent out to a sister facility that also uses a roche analyzer and an abbott architect analyzer for the troponin t and troponin i assays respectively.On (b)(6) 2021 at 9:00 pm, the troponin t initial result from the e 602 module was 4.1 ng/ml.The troponin i initial result from the abbott architect was <0.01 (the unit of measurement was not specified).The reporter stated that this troponin t result did not match the clinical picture of the patient; they believed that the troponin i was the accurate result.On (b)(6) 2021 at 9:00 am, the troponin t result of the new sample from the e 602 module was 4.9 ng/ml.The troponin i result from the abbott architect was <0.01 (the unit of measurement was not specified).The troponin t repeat result of the new sample after recalibration of the assay on the e 602 module was 4.69 ng/ml.The troponin t repeat result from the sister facility's roche analyzer was approximately 4.0 ng/ml.The troponin i repeat result from their abbott architect was <0.01 (the unit of measurement was not specified).It was reported that the sample was sent to another sister facility that uses a roche analyzer for the troponin t assay and the result obtained from this analyzer was compatible with the results obtained from the other roche analyzers used.
Additional Manufacturer Narrative
The alarm trace did not indicate an issue.The calibration performed on (b)(6) 2021 did not indicate an issue.The pre-analytical data was requested but not provided.A general reagent instrument problem can be excluded because the troponin t results have been reproduced at two other sites which use roche instruments.Furthermore, the instrument's maintenance was up to date and the customer did not have any calibration or qc issues.The customer also declined to have the field service engineer (fse) dispatched.The customer was comparing results from the troponin t assay to results from the troponin i assay.These are different assays.Where troponin i is intended to aid in the diagnosis of myocardial infarction only, troponin t has several other intended uses.Per troponin t stat product labeling: "this assay can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.G.Acute myocardial infarction.The test is further indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure.The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac troponin." the investigation did not identify a product problem.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13358383
• Report Number: 1823260-2022-00209
• Device Sequence Number: 4104482
• Product Code: MMI
• UDI-Device Identifier: 04015630921621
• UDI-Public: 04015630921621
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 02/24/2022

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 Catalogue Number: 04660307190
• Device Lot Number: 52076700
• 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: 01/31/2022
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 02/24/2022
• 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 Sex: Unknown