BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1211572 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02739
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER METER, STRIPS, OR CONTROL SOLUTION 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 THAT A ONE TOUCH ULTRALINK METER WAS READING INACCURATELY HIGH. THE PATIENT TESTS HER BLOOD GLUCOSE 5-6 TIMES A DAY. SHE TAKES SLIDING-SCALE NOVOLOG INSULIN VIA AN INSULIN PUMP. THE PATIENT TAKES THE INSULIN BASED ON "CARB-COUNTING" AND HER METER READINGS. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON THREE DAYS EARLIER, AT AN UNKNOWN TIME. THE PATIENT MENTIONED THAT THE METER STARTED GIVING READINGS OF "HIGH." ACCORDING TO THE OWNER'S MANUAL, A RESULT OF "HIGH GLUCOSE" MAY INDICATE A BLOOD GLUCOSE LEVEL EXCEEDING 600 MG/DL. ON THE DAY PRIOR TO ORIGINAL DATE, THE PATIENT MENTIONED THAT SHE HAD GOTTEN RESULTS OF "HIGH" ALL DAY. BASED ON THE METER RESULTS OF "HIGH" SHE HAD GOTTEN EARLIER THAT DAY, THE PATIENT TOOK UNSPECIFIED DOSAGES OF SLIDING-SCALE INSULIN. AT AN UNKNOWN TIME LATER THAT SAME DAY, THE PATIENT CLAIMED THAT SHE "BLACKED OUT, WAS SLUMPED OVER, AND HAD A COLD SWEAT." THE PATIENT'S HUSBAND APPARENTLY TESTED HER WITH THE REPORTED METER WHILE SHE WAS SYMPTOMATIC AND GOT ANOTHER RESULT OF "HIGH." THE PARAMEDICS WERE CONTACTED. THE PARAMEDICS TESTED THE PATIENT'S BLOOD GLUCOSE WITH AN EMT METER AND GOT A RESULT OF "24MG/DL." THE PATIENT WAS REPORTEDLY TREATED WITH IV FLUIDS (UNKNOWN CONTENTS) TO RAISE HER BLOOD GLUCOSE. SHE WAS TAKEN TO A HOSPITAL WHERE SHE STAYED FOR A FEW HOURS UNTIL HER SYMPTOMS WERE RELIEVED. THE PATIENT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PATIENT WAS OBTAINING BLOOD SAMPLES FROM HER FINGERS BUT WAS NOT CLEANING THE PUNCTURE SITES CORRECTLY. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND RECEIVED MEDICAL TREATMENT FROM PARAMEDICS AFTER THE ALLEGED METER ISSUE BEGAN. THE PATIENT CLAIMED THAT THE SYMPTOMS DEVELOPED AFTER TAKING SLIDING-SCALE INSULIN BASED ON INACCURATE HIGH METER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2828969

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R