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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS MYOGLOBIN MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM Back to Search Results
Catalog Number 12178214122
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2018
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
 
Event Description
The customer stated that they received erroneous results for one patient sample tested for the elecsys myoglobin immunoassay (myo) on an unknown roche analyzer. No erroneous results were reported outside of the laboratory. The sample initially resulted as 1300 ng/ml. The sample was diluted manually x11 and then repeated with a x100 automatic dilution, resulting with a final value of 289000 ng/ml. The sample was also diluted manually x21 and then repeated with a x100 automatic dilution, resulting with a final value of 350000 ng/ml. No adverse events were alleged to have occurred with the patient. The model and serial number of the roche analyzer were asked for, but not provided. It was suspected that the sample exhibited a prozone effect since the myo value exceeds 30000 ng/ml. Product labeling indicates that there is no high-dose hook effect at myoglobin concentrations up to 30000 ng/ml. No foam or clots were visible within the sample.
 
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Brand NameMYOGLOBIN
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 Key7548542
MDR Text Key109902294
Report Number1823260-2018-01618
Device Sequence Number1
Product Code DDR
Combination Product (y/n)N
Reporter Country CodeJA
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 06/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number12178214122
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 Received05/09/2018
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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