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

Catalog Number	04660307190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A roche representative had been at the customer site to perform technical tasks on multiple analyzers including this cobas 6000 e 601 module.The elecsys troponin t stat assay (troponin t stat) had been removed from the module during this time requiring the customer to recalibrate and run qc once it was put back on.The customer then began testing patient samples.At approximately 5:15 p.M.The laboratory was notified that a trend had been noticed for troponin t stat results for patient samples.All troponin t stat results were either 0.04 ng/ml or higher when the expected results were 0.01 ng/ml or below.The customer stopped running patient samples and ran qc which was outside of the acceptable range.The customer stated 23 patients had been run and troponin t stat results had been reported outside of the laboratory between 11:30 a.M.And 12:00 p.M.The customer starting repeating and correcting patient results between 5:30 p.M.And 10:00 p.M.Refer to attached data for patient results.The customer made new calibrator material and recalibrated the assay.After recalibrating, the qc results were within range.The customer was not aware of any patients being treated based on the incorrect results.Some patients were admitted to the hospital, but the customer was not sure if they would have been admitted due to symptoms of chest pain regardless of the troponin t stat result.There was no allegation that an adverse event occurred.The e601 module serial number was (b)(4).The customer declined a service visit since the issue was resolved.Based on the data provided, the calibration results performed after the service actions were lower than the acceptable ranges.This low calibration signal caused the patient results to recover high.Qc was out of the acceptable range at this time but was not noticed.The customer is using sample tubes with no rack adapters.The centrifugation speed and time was not as recommended by the tube manufacturer.The investigation determined the issue was resolved by the recalibration performed by the customer.

• 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
• MDR Report Key: 7792859
• Report Number: 1823260-2018-02755
• Device Sequence Number: 11085314
• Product Code: MMI
• UDI-Device Identifier: 04015630921621
• UDI-Public: 4015630921621
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: 04/30/2019
• Device Catalogue Number: 04660307190
• Device Lot Number: 30870401
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1