BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1051871 · Received May 21, 2008

    Report

    Report Number
    2939301-2008-00854
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 12, 2008
    Report Date
    May 2, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE ONE TOUCH ULTRA EASY METER WOULD NOT TURN ON. THE MEDICAL AFFAIRS SPECIALIST SENT FOLLOW-UP QUESTIONS TO THE TECHNICAL SERVICE REPRESENTATIVE (TSR) TO ASK THE PATIENT. THE PATIENT STATED THAT OVER THE LAST 2-3 WEEKS THE METER WOULD NOT TURN ON. DURING THIS TIME, SHE HAS EPISODES WHERE SHE FEELS THIRSTY, WHICH SHE CORRELATES TO HYPERGLYCEMIA AND SHAKINESS, WHICH SHE THINKS IS TYPICAL WHEN SHE IS HYPOGLYCEMIC. SHE STATED SHE WOULD FIRST FEEL THIRSTY THEN FEEL SHAKY WITHIN AN UNKNOWN AMOUNT OF TIME AND STATED THIS HAPPENED 2-3 TIMES DURING THE 2-3 WEEK PERIOD. WHEN SHE FELT SHAKY, SHE WOULD ADMINISTER LESS INSULIN AND EAT CHOCOLATE, AND WHEN SHE FELT THIRSTY, SHE WOULD ADMINISTER MORE INSULIN. DURING THE 2-3 TIMES SHE HAD SYMPTOMS, SHE ADJUSTED HER INSULIN BETWEEN 1 AND 4 UNITS, INCLUSIVE. SHE FELT BETTER ABOUT 30-60 MINUTES EACH TIME SHE ADJUSTED HER INSULIN. THE PATIENT TAKES NOVORAPID INSULIN 7-8 UNITS IN THE MORNING, 8 UNITS AT LUNCHTIME, 10 UNITS IN THE EVENING AND 14 UNITS OF GLARGINE AT BEDTIME. SHE INCREASES HER INSULIN WHEN HER READING IS ABOVE 9.0 MMOL/L AND DECREASES IT WHEN HER READING IS UNDER 2.0 MMOL/L. SHE TESTS HER BLOOD SUGAR TWICE PER DAY. SHE SAYS SHE WOULD NOT HAVE DONE ANYTHING DIFFERENTLY REGARDING TREATMENT EVEN IF SHE WERE ABLE TO TEST DURING THE 2-3 WEEK PERIOD THAT THE METER DID NOT TURN ON. SHE HAS NOT HAD ANY SYMPTOMS SINCE SHE CALLED LIFESCAN BUT DID MENTION SHE CONTRACTED AN INFECTION AND GOT SICK ON TWO DAYS PRIOR TO ORIGINAL DATE. IT WAS DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL, THE PATIENT REPLACED THE BATTERIES PER THE OWNER'S MANUAL. THE BATTERY CONTACTS WERE IN GOOD CONDITION AND THE METER DOES NOT TURN ON BY PRESSING THE POWER BUTTON OR INSERTING THE TEST STRIP ALL THE WAY INTO THE PORT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED SHE HAD SYMPTOMS THAT SHE BELIEVED WERE CHARACTERISTIC OF HYPOGLYCEMIA AND HYPERGLYCEMIA WHILE THE METER REPORTEDLY WOULD NOT TURN ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2683880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening| R