MYOGLOBIN STAT (SHORT TURN AROUND TIME) (MYOGLOBIN STAT) 11820788160

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-06 for MYOGLOBIN STAT (SHORT TURN AROUND TIME) (MYOGLOBIN STAT) 11820788160 manufactured by Roche Diagnostics.

Event Text Entries

[1971665] The user received a questionable myoglobin result for one patient sample from the elecsys 2010 disk analyzer (b)(4). The initial result was 1244 ng/ml and was reported outside the laboratory. The sample was repeated due to the patient's history and the repeat results were 100. 6 ng/ml and 88 ng/ml. Additional repeat testing was performed on the sample. The specific results were not provided, but the user stated they recovered similarly to the first repeat result. The patient was not adversely affected. Upon evaluation of the analyzer, the field service representative determined the bead mixer was rotating too fast and the probe was adjusted too high. He adjusted the bead mixer speed and the probe height. To verify the analyzer operation, he ran performance testing and precision tests which passed. The user ran quality control with results within their acceptable range.
Patient Sequence No: 1, Text Type: D, B5


[9130450] It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1823260-2011-03045
MDR Report Key2114721
Report Source05,06
Date Received2011-06-06
Date of Report2011-06-06
Date of Event2011-05-19
Date Mfgr Received2011-05-21
Date Added to Maude2011-06-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactNA RAE ANN FARROW
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175213194
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 118 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG) 68300
Manufacturer Postal Code68300
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameMYOGLOBIN STAT (SHORT TURN AROUND TIME) (MYOGLOBIN STAT)
Generic NameMYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
Product CodeDDR
Date Received2011-06-06
Model NumberNA
Catalog Number11820788160
Lot Number16083102
ID NumberNA
Device Expiration Date2012-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9118 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250


Patients

Patient NumberTreatmentOutcomeDate
10 2011-06-06

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