BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 2860932 · Received December 6, 2012

    Report

    Report Number
    1832816-2012-00112
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION PRIME METER WAS READING HIGH. CALLER STATED IT "(B)(4) NEAR KILLED ME." METER READ 274 SO HE DOSED WITH INSULIN AND 15 MINUTES LATER HE WAS ON THE FLOOR. PARAMEDICS WERE CALLED AND THEY TOOK HIM TO THE HOSPITAL. HE COMPARED THE PRIME METER WITH THE HOSPITAL METER AND IT READ 140-150 POINTS OFF. (B)(6) 2012 CALLED BACK TO FILL OUT INCIDENT REPORT. CALLER STATED HE USUALLY GETS TO WORK AROUND 10PM AND THEN HE CHECKS HIS SUGAR AT 11PM AND BASED ON HIS READINGS HE TOOK MORE INSULIN THAN USUAL. AFTER 20 MINUTES HE FELL ON THE FLOOR DUE TO OVERDOSING HIMSELF. HE WOKE UP WHILE HE WAS ON THE FLOOR AND SOMEONE FROM WORK CALLED THE PARAMEDICS. WITH THE PARAMEDIC'S METER HE GOT A LOW READING AND WITH HIS RELION HE GOT 140. THE PARAMEDICS GAVE HIM IV FLUIDS. SYMPTOMS AT TIME OF THE INCIDENT WERE HOT FLASHES, HIS LIPS START TO TINGLE, SWEATING AND HEADACHE. AFTER THE INCIDENT HE WENT TO THE HOSPITAL TO DOUBLE CHECK HE WAS IN GOOD CONDITIONS. CURRENTLY HE IS FEELING BETTER NOW. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701102 08282B

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R