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INRATIO Adverse Event — Malfunction (MDR 2954730-2008-00076)

INRATIO Adverse Event — Malfunction (MDR 2954730-2008-00076) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: INRATIO; Generic name: PROTHROMBIN TIME TEST; Manufacturer: HEMOSENSE SJ.

DeviceINRATIO
Generic namePROTHROMBIN TIME TEST
ManufacturerHEMOSENSE SJ
Report number2954730-2008-00076
Event typeMalfunction
Product problemY
Date received2008-02-19
Report sourceUnknown
NarrativeCALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2007; INRATIO: >7.5; LAB: 1.7 (NEXT DAY).
SourceopenFDA MAUDE (device adverse events)

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