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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS MYOGLOBIN IMMUNOASSAY MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM

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ROCHE DIAGNOSTICS ELECSYS MYOGLOBIN IMMUNOASSAY MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM Back to Search Results
Catalog Number 12178214160
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/31/2016
Event Type  malfunction  
Manufacturer Narrative
Expiration date was provided as (b)(6) 2017. This event occurred in (b)(6). (b)(4).
 
Event Description
The customer questioned high results for 1 patient tested for elecsys myoglobin immunoassay (myoglobin) on a cobas 8000 e 602 module that did not fit the clinical picture for this patient. The patient was hospitalized due to kidney failure. The patient¿s myoglobin results for more than 2 weeks were >3000 ug/l. The customer inquired if there is an interference with the myoglobin assay and the medications the patient is being treated with. Refer to attached data for the patient results. No adverse event occurred. The e602 module serial number was (b)(4). A specific root cause could not be identified for this event. Additional information was requested for investigation but was not provided. Since the patient has kidney failure, myoglobin results could be elevated due to the disease. It is also possible that the medications the patient is being treated with are having a cardio toxic effect increasing the myoglobin results. However, since no patient samples could be provided, this could not be confirmed.
 
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Brand NameELECSYS MYOGLOBIN IMMUNOASSAY
Type of DeviceMYOGLOBIN IMMUNOLOGICAL TEST SYSTEM
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 Key6326819
MDR Text Key67339259
Report Number1823260-2017-00299
Device Sequence Number1
Product Code DDR
Combination Product (y/n)N
Reporter Country CodeLO
PMA/PMN Number
K083260
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number12178214160
Device Lot Number133148-01
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 Received01/25/2017
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

Patient Treatment Data
Date Received: 02/13/2017 Patient Sequence Number: 1
Treatment
BETALOZ; FRAXIPARINE; KUMULIN R; LINEZOLID; MEROPENEM; MILURIT; MYCOMAX; NOLPAZA
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