BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1013130 · Received March 11, 2008

    Report

    Report Number
    2939301-2008-00290
    Event Type
    Injury
    Date Received
    March 11, 2008
    Report Date
    March 3, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    METER SERIAL # AND TEST STRIP LOT # WERE NOT PROVIDED. LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D 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 THE FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/RPTR IN FRANCE, THE PT'S WIFE, CONTACTED LIFESCAN, INC (LFS) ALLEGING THE ONE TOUCH ULTRA 2 METER WAS GIVING INACCURATELY HIGH READINGS. ON TWO DAYS LATER, THE TECHNICAL SVC REP (TSR) SPOKE WITH THE RPTR TO OBTAIN AND VERIFY INFO. ON AN UNSPECIFIED EVENING IN TWO MONTHS PRIOR TO ORIGINAL MONTH, THE PT OBTAINED A BLOOD GLUCOSE READING USING THE REPORTED METER THAT WAS HIGHER THAN HIS EXPECTED READINGS. THE PT WAS UNABLE TO PROVIDE THE SPECIFIC RESULT. THE PT STATED HE TOOK AN INCREASED DOSE OF ACTRAPID INSULIN BASED ON THIS METER READING. THE PT WAS UNABLE TO STATE WHETHER OR NOT HE WAS EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS AT THAT TIME. AT 6:45 AM THE NEXT MORNING, THE PT EXPERIENCED THE SYMPTOM OF LOSS OF CONSCIOUSNESS. THE PT HAD NOT TAKEN ANY MEAL OR MEDICATION, OR TESTED HIS BLOOD GLUCOSE LEVEL, PRIOR TO BECOMING UNCONSCIOUS. THE PT'S WIFE ADMINISTERED A GLUCAGON INJECTION, AND THE PT WAS REVIVED TEN MINS LATER. THE PT'S WIFE CONTACTED EMERGENCY SVS. PARAMEDICS ARRIVED, HOWEVER THEY DID NOT TEST THE PT'S BLOOD GLUCOSE LEVEL NOR DID THEY ADMINISTER ANY TREATMENT. THE PT REFUSED TO BE TRANSPORTED TO THE ER. THE PT TAKES 13 UNITS LANTUS INSULIN EACH EVENING, AND ACTRAPID INSULIN THREE TIMES PER DAY ON A SLIDING SCALE BASED ON METER READINGS. THE PT TESTS HIS BLOOD GLUCOSE LEVEL SIX TIMES PER DAY. THE PT'S OTHER MEDICAL CONDITIONS ARE OSTEOARTHRITIS AND ANEMIA. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE TSR DETERMINED THE PT'S TESTING TECHNIQUE WAS CORRECT, AND THE METER WAS PROGRAMMED FOR THE CURRENT UNIT OF MEASURE. THE TSR ALSO DETERMINED THAT THE PT WAS INCORRECTLY CLEANING THE PUNCTURE SITE PRIOR TO PERFORMING THE FINGERSTICK, WHICH CAN CAUSE INACCURATE READINGS. ACCORDING TO THE PACKAGE INSERT FOR THE ONE TOUCH ULTRA TEST STRIPS, HEMATOCRIT LEVELS LESS THAN 30% MAY LEAD TO INACCURATELY HIGH BLOOD GLUCOSE READINGS. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE SPECIFIC METER READINGS OBTAINED PRIOR TO THE EVENT, THE DOSE OF INSULIN TAKEN BASED ON THE METER READINGS, THE TIMES OF THE READINGS AND THE INSULIN DOSES, AND THE PT'S EXPECTED READINGS. THE PT INCORRECTLY CLEANED HIS FINGERS PRIOR TO TESTING, AND ALSO SUFFERS FROM ANEMIA, BOTH OF WHICH MAY AFFECT THE ACCURACY OF THE METER READINGS. THE PT ALLEGEDLY BECAME HYPOGLYCEMIC AND FELL UNCONSCIOUS FOLLOWING AN INSULIN DOSE BASED ON METER READINGS. THE PT REC'D EMERGENCY MEDICAL ATTN IN THE FORM OF A GLUCAGON INJECTION TO RESOLVE THE SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R