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

Catalog Number	05094798160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained of erroneous high results for 2 patient samples tested for elecsys troponin i stat immunoassay (troponin i stat) on 2 cobas 6000 e 601 modules.The e601 module serial numbers were (b)(4).Patient 1 initial result from the e601 module was 3.35 ng/ml.Patient 2 (male, date of birth (b)(6)) initial result from the e601 module was 2.08 ng/ml.The initial results were reported outside of the laboratory where medical personnel questioned them.Both patient samples were repeated by the istat method and the ortho-vitros method with negative results (0.0 ng/ml).The customer repeated both patient samples on a different e601 module and obtained "positive" results again.The actual results were not provided.The samples were repeated again by the istat method with negative results (0.0 ng/ml).The negative results from the istat and ortho-vitros methods were believed to be correct.The customer did not have issues with any other patients tested for troponin i stat on the e601 modules.The customer thinks there may be some sort of interference in these patient samples affecting the results from the e601 modules.No adverse event occurred.The field service engineer (fse) visited the customer site and ran instrument checks on both e601 modules.All probe alignments, liquid level detection and instrument performance check results passed with no issues.There were no known interferences with the medications the patients are taking.The investigation was unable to determine a definitive root cause.
Additional Manufacturer Narrative
The high tni result could be confirmed, tnt hs are in all samples within the normal range.An interference against a component of the reagent was confirmed in the samples.The interference is consistent with a human anti-mouse antibody (hama).This interference is documented in the product labeling.No product problem was found.
Additional Manufacturer Narrative
The customer provided additional questionable troponin i stat results for both patients obtained between 03-jul-2018 and 05-aug-2018 compared to the abbott istat method.(b)(4).

• 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
• MDR Report Key: 7739280
• Report Number: 1823260-2018-02540
• Device Sequence Number: 13732722
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2019

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: 05094798160
• Device Lot Number: 295504
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018; 07/16/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/27/2018; 01/31/2019
• 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: PATIENT 1 - ATORVASTATIN; PATIENT 1 - CELEXA; PATIENT 1 - CLINDAMYCIN; PATIENT 1 - LOVENOX; PATIENT 1 - NAPROXEN; PATIENT 1 - OXYCODONE; PATIENT 1 - REGALIN; PATIENT 1 - TOPORAL; PATIENT 1 - TYLENOL; PATIENT 2 - ATORVASTATIN; PATIENT 2 - BUPROPRION; PATIENT 2 - INSULIN INJECTIONS; PATIENT 2 - LISINOPRIL; PATIENT 2 - METFORMIN; PATIENT 2 - MULTIVITAMIN WITH MINERALS; PATIENT 2 - SITAGLIPTIN; PATIENT 2 - TOPOROL; PATIENT 2- INVOKANA
• Patient Age: 37 YR
• Patient Weight: 101