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

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.

• Brand Name: TROPONIN T HIGH SENSITIVE
• 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: 6263188
• MDR Text Key: 65239247
• Report Number: 1823260-2017-00103
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K961500
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05092744190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/19/2017
• 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
• Treatment: QIZENDAY
• Patient Outcome(s): Death