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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 07027583190
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The initial reporter complained of discrepant low results for 1 patient sample tested for elecsys myoglobin (myoglobin) on a cobas e801 module. The initial result was 2042 ug/l. The sample was repeated twice with results of 1880 ug/l and 1753 ug/l. On (b)(6) 2020 the customer repeated the sample using a 1:50 dilution and a 1:100 dilution with results of >150,000 ug/l and 272,737 ug/l respectively. The result of 272,737 ug/l was reported outside of the laboratory. Previous samples from the patient had very high myoglobin results (330,000 ug/l and 195,000 ug/l). No questionable low results were reported outside of the laboratory. The e801 module serial number was (b)(4).
 
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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 Key10185653
MDR Text Key221584840
Report Number1823260-2020-01518
Device Sequence Number1
Product Code DDR
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K083260
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,Followup
Report Date 08/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Catalogue Number07027583190
Device Lot Number439456
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 Received05/29/2020
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

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