BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1051865 · Received May 21, 2008

    Report

    Report Number
    2939301-2008-00846
    Event Type
    Injury
    Date Received
    May 21, 2008
    Report Date
    April 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST 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 THE 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

    ON (B)(6) 2008, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH. THE PT TESTS HER BLOOD GLUCOSE 2-4 TIMES A DAY. SHE TYPICALLY TESTS TWICE DURING THE MORNING, ONCE IN THE AFTERNOON, AND WHENEVER SHE FEELS SYMPTOMATIC. THE PT TAKES A SET DOSE OF METFORMIN ONCE A DAY IN THE MORNING REGARDLESS OF HER METER READINGS. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ABOUT 2-3 MONTHS AGO ON AN UNSPECIFIED DATE/TIME. SHE ADMITTED, HOWEVER, THAT THE METER STARTED READING INACCURATELY HIGH AFTER SHE HAD DROPPED THE METER IN WATER. SHE WAS UNABLE TO PROVIDE A DATE/TIME WHEN THE DEVICE WAS DROPPED IN WATER. IN ONE INSTANCE, THE PT REPORTED BLOOD GLUCOSE RESULTS OF "300 MG/DL" WITH THE LIFESCAN METER AND "147 MG/DL" ON HER FRIEND'S UNIDENTIFIED METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PT COULD NOT REMEMBER FURTHER DETAILS REGARDING THE METER-TO-OTHER METER COMPARISON. IN ANOTHER INSTANCE, THE PT REMEMBERED FEELING SHAKY AND LIKE HER BLOOD GLUCOSE WAS LOW. SHE TESTED HER BLOOD GLUCOSE WHILE HAVING THE SYMPTOMS AND GOT A READING OF "145 MG/DL." THE PT DRANK WATER AND ATE CANDY WHICH HELPED TO RELIEVE HER SYMPTOMS. THE PT COULD NOT REMEMBER WHAT BLOOD GLUCOSE READINGS SHE GOT OR WHAT ACTIONS SHE TOOK BEFORE DEVELOPING THE SYMPTOMS. THE PT MENTIONED, HOWEVER, THAT SINCE HER BLOOD GLUCOSE READINGS WERE RELATIVELY HIGH, SHE "WATCHED HER DIET: AND LIMITED WHAT SHE ATE. THE PT DENIED SEEKING OR RECEIVING MEDICAL ATTENTION FROM A HEALTH CARE PROVIDER AS A RESULT OF THE REPORTED METER ISSUE. THE PT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PT WAS OBTAINING BLOOD SAMPLES FROM HER FINGERS AND 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 PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER INACCURACY ISSUE BEGAN. SHE COULD NOT RECALL WHAT ACTIONS SHE TOOK BEFORE DEVELOPING THE SYMPTOMS. ALSO, HER REPORTED METER READING DID NOT CORRELATE WITH HER REPORTED SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2785035

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R