MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE CARDIAC, TROPONIN T QUANTITATIVE; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number ASKU

Device Problem False Alarm (1013)

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

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received an erroneous alarm from their cobas h 232 analyzer when testing troponin t quantitative (tnt) on one patient sample.The customer stated that this is not the only occasion where this issue occurred, but provided no further information.The cobas h 232 analyzer is not sold in the united states, nor is it like or similar to a product sold in the united states.The date of the event was asked for, but not provided.The cobas h 232 analyzer alarmed that it detected an elevated tnt result during measurement of the sample.A nurse operating the analyzer was on the phone with the doctor and informed the doctor of the elevated tnt result alarm.When measurement of the sample was complete, it had a final result of below 50 ng/l.The patient was prescribed medication based on the elevated tnt alarm.It was asked, but it is not known if the patient was adversely affected due to receiving the prescription.No adverse events were alleged.The cobas h 232 analyzer serial number was (b)(4).

Manufacturer Narrative

It has been confirmed that the patient was treated with one aspirin in response to the high tnt alarm.The patient was hospitalized and has now been released from the hospital.The patient was provided litalgin iv and perfalgan in the ambulance prior to sample collection.The date of the event is (b)(6) 2015.Medwatch the date received by the manufacturer is (b)(4) 2015.

• Brand Name: ROCHE CARDIAC, TROPONIN T QUANTITATIVE
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5261947
• MDR Text Key: 32580233
• Report Number: 1823260-2015-04657
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K000784
• 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
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 11/12/2015
• 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