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

Catalog Number	05094798160
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The qc was reported to be within normal ranges.The alarm trace revealed an abnormal probe sucking alarm surrounding the time of the event.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys troponin i stat immunoassay result for one patient sample tested on a cobas 6000 e 601 module with serial number (b)(4).On (b)(6) 2021, the initial result was reported to the physician.On the same day, the patient was transported to another facility where a negative unspecified troponin result was obtained on a new sample from the patient.The pathologist of the laboratory also questioned the result and requested that the initial plasma sample be sent to another laboratory for a rerun.The laboratory uses a vitros analyzer with an unknown laboratory method.The repeat result was deemed correct.The initial result of the plasma sample in a primary tube at 8:40 am was 2.8 ng/ml.The repeat result of the plasma aliquot sample from the other laboratory was <0.012 ng/ml.
Additional Manufacturer Narrative
The patient sample from on (b)(6) 2021 is no longer available for investigation.The customer confirmed that the instrument is working within specifications as they sent 3 different patient samples to other laboratories and obtained the same results for the other patients.There were no issues noted with the repeats of the other samples.The cause of the event could not be determined.

• Brand Name: ELECSYS TROPONIN I STAT IMMUNOASSAY
• 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: 13417626
• Report Number: 1823260-2022-00264
• Device Sequence Number: 4690225
• Product Code: MMI
• UDI-Device Identifier: 04015630939381
• UDI-Public: 04015630939381
• 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): 02/28/2022

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: 05/31/2022
• Device Catalogue Number: 05094798160
• Device Lot Number: 52301801
• 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: 01/11/2022
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 02/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN.; ATORVASTATIN.; CARVEDILOL.; OMEPRAZOLE.
• Patient Age: 33 YR
• Patient Sex: Male