MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TROPONIN T HIGH SENSITIVE STAT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 05092728190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).(b)(4).

Event Description

The customer received questionable troponin t hs stat results for one patient and suspected interference.The initial result was 65 ng/l which was not consistent with the diagnosis for the patient.The repeat result was 70 ng/l.The site ran the sample 10 times for precision testing and the results were very inconsistent.Another sample was requested by the laboratory on the same day and the results also showed the same trend.A sample from the patient was sent to another laboratory for testing and the results were also questionable.The type of analyzer used at the other laboratory was not provided.Refer to the attachment to the medwatch for all the patient data.The results of 65 ng/l, 79.4 ng/l, 145 ng/l were reported outside the laboratory.There was no allegation of an adverse event.The customer performed precision testing on samples from other patients and the results were acceptable.The customer ran a precision check with qc material which was acceptable.The customer used a cobas 6000 e 601 module.The serial number was requested but was not provided.

Manufacturer Narrative

Seven samples from the patient were submitted for investigation and were tested in duplicate for troponin i, troponin t, and troponin t hs stat with good agreement between the results.High results were seen for troponin t hs stat and troponin i.(b)(6).

Manufacturer Narrative

Further testing of the patient samples by serum fractionation indicated an interference caused by a high molecular weight compound, presumably igm.This interference caused the falsely elevated troponin t hs stat results.This type of interference is extremely rare and is documented in product labeling for the assay.The incident rate for this type of confirmed interference, based on global complaints and tests sold between january 2009 and june 2017 was 25 in 269 million tests sold.

• Brand Name: TROPONIN T HIGH SENSITIVE STAT
• Type of Device: 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: 6611120
• MDR Text Key: 76743332
• Report Number: 1823260-2017-01151
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K051752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 05092728190
• Device Lot Number: 17645201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1