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	08/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer received questionable elecsys troponin i stat immunoassay results from cobas 6000 e 601 module serial number (b)(4).The initial result was 1.59 ng/ml (positive) and was reported outside of the laboratory.The repeat result was 1.57 ng/ml (positive).The patient was admitted to the hospital based on the results.The patient was tested using an abbott i-stat and the result was 0.02 ng/ml (negative).There was no allegation of an adverse event.The field service representative inspected the instrument and gear pump pressure, checked the probe alignments and spline set screws.He performed a precision check, mechanical check, and operational checks which all passed successfully.
Additional Manufacturer Narrative
The customer provided clarification that the left heart catherization documented in the attachment to the initial medwatch was performed based on the positive troponin result.There was no allegation that the patient was adversely affected.The patient is currently in a "step down unit" and out of the icu.The customer believed the result from the abbott i-stat to be correct.
Additional Manufacturer Narrative
The investigation confirmed tni stat positive results and negative tnt hs results with the samples.The fractionation of the sample indicates an interference by an igm molecule consistent with a human anti-mouse antibody (hama).Potential interference by an igm molecule is covered in the method sheet.
Additional Manufacturer Narrative
The customer provided samples for testing.The investigation found when testing tni and tni stat all samples are above normal range.When testing tnt hs all samples are within normal range.

• 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: 7872794
• Report Number: 1823260-2018-03115
• Device Sequence Number: 16200107
• 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,Followup
• Report Date (Section B): 12/11/2018

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: 02/28/2019
• Device Catalogue Number: 05094798160
• Device Lot Number: 29550400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 08/27/2018; 08/27/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 09/24/2018; 10/31/2018; 12/11/2018
• 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 Weight: 104