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TRUE METRIX Adverse Event — Malfunction (MDR 1000113657-2020-00258)

TRUE METRIX Adverse Event — Malfunction (MDR 1000113657-2020-00258) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TRUE METRIX; Generic name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER; Manufacturer: TRIVIDIA HEALTH INC.

DeviceTRUE METRIX
Generic nameSYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
ManufacturerTRIVIDIA HEALTH INC
Report number1000113657-2020-00258
Event typeMalfunction
Product problemN
Date received2020-04-27
Report sourceCONSUMER
NarrativeINTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR AND SYMPTOMS RELATED TO DIABETES - THIRSTY
SourceopenFDA MAUDE (device adverse events)

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