• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS TROPONIN T HIGH SENSITIVE IMMUNOASSAY METHOD, TROPONIN SUBUNIT Back to Search Results
Catalog Number 05092744190
Device Problem Low Test Results (2458)
Patient Problem Death (1802)
Event Date 09/08/2016
Event Type  Death  
Manufacturer Narrative
This event occurred in (b)(6). (b)(4). Date of death - the date of death was requested, but not provided. The date in date of death is an approximate date.
 
Event Description
The customer stated that a patient with multiple sclerosis was admitted in the emergency room with chest pain. The patient was tested on (b)(6) 2016 with the elecsys troponin t hs assay (tnths) on a cobas 8000 e 602 module (e602) and the result was < 5 ng/l which is a negative result. The patient was admitted to the intensive care unit (icu) for an unknown reason. Since the initial tnths result was negative, no other tnths testing was performed. On (b)(6) 2016, 5 days later, the patient was tested again for tnths and the result was 55 ng/l. The laboratory then discovered that the patient was taking qizenday (biotin) at the time of admission to the hospital. The biotin medication was stopped while the patient was in the icu. The patient had a high nt probnp at this time. Product labeling documents samples should not be taken from patients receiving therapy with high biotin doses (i. E. > 5 mg/day) until at least 8 hours following the last biotin administration. The dosage of biotin was requested but not provided. The patient died in the icu. The following information has been requested but not provided: additional tests performed in the emergency room and results of those tests, including both laboratory and any other diagnostic testing. The patient¿s diagnosis upon admission to the hospital. Treatment and lab tests performed during the 5 days between the patient¿s hospital admission and subsequent death, and; the cause of death. No sample from the patient is available; therefore a full investigation of the event could not be performed. Product labeling documents an initial negative tnths result does not rule out myocardial infarction in all patients. Additional testing at appropriate time intervals is indicated if the first measurements are not conclusive and the clinical condition is still suggestive of acs. In this event, the second tnths measurement was performed 5 days after initial testing, which is not in line with clinical recommendations. In addition, it is clinically plausible the tnths result could increase over a 5 day period. There is no information to reasonably suggest the initial negative tnths result was incorrect.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTROPONIN T HIGH SENSITIVE
Type of DeviceIMMUNOASSAY 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 Key6263188
MDR Text Key65239247
Report Number1823260-2017-00103
Device Sequence Number1
Product Code MMI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K961500
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number05092744190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2016
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

Patient Treatment Data
Date Received: 01/19/2017 Patient Sequence Number: 1
Treatment
QIZENDAY
-
-