BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1040239 · Received May 7, 2008

    Report

    Report Number
    2939301-2008-00691
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 13, 2008
    Report Date
    April 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS AND CONTROL SOLUTION FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER, STRIPS AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVAL 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/REPORTER CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRASMART METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE TO THE RPTR ON APRIL 29, 2008, AND OBTAINED/VERIFIED INFO. THE PT TESTS HIS BLOOD GLUCOSE 8 TIMES A DAY. HE TAKES HUMALOG INSULIN ON A BASAL RATE VIA AN INSULIN PUMP. IN ADDITION, HE TAKES SLIDING SCALE BOLUS DOSAGES OF THE HUMALOG INSULIN BASED ON HIS METER READINGS. THE RPTR INDICATED THAT THE ALLEGED METER ISSUE HAD BEEN OCCURRING FOR ABOUT A MO. IN ONE INSTANCE, THE PT OBTAINED BLOOD GLUCOSE RESULTS OF "150 MG/DL" WITH THE REPORTED LFS METER AND "101, 102 AND 100 MG/DL" ON A METER USED IN A DR'S OFFICE, PERFORMED WITHIN 10 MINS 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 RPTR ADDED THAT IN ANOTHER CASE WILE THE PT WAS AT SCHOOL, HE TOOK SLIDING-SCALE HUMALOG INSULIN BASED ON A METER RESULT, THE RPTR FELT WAS INACCURATELY HIGH. AN UNK TIME LATER, THE PT DEVELOPED SYMPTOMS OF SHAKINESS, CONFUSION, SWEATING, DISORIENTATION, AND INABILITY TO WALK. WHILE THE PT WAS SYMPTOMATIC, HE RETESTED HIS BLOOD GLUCOSE AND GOT RESULTS THAT WERE "NORMAL" AND "OVER 100 MG/DL". THE PT WAS TAKEN TO AN EMERGENCY ROOM (ER) WHERE HE WAS TOLD THAT HIS BLOOD GLUCOSE WAS LOW. THE RPTR DID NOT KNOW WHAT RESULTS WERE OBTAINED. THE PT WAS TREATED WITH ORAL GLUCOSE. THE PT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PT WAS OBTAINING BLOOD SAMPLES FROM HIS FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. THE RPTR PERFORMED A CONTROL SOLUTION TEST WITH THE REPORTED TEST STRIPS AND TEST STRIPS FROM A NEW VIAL. BOTH TESTS PASSED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE RPTR CLAIMED THAT THE PT BECAME HYPOGLYCEMIC AFTER TAKING INSULIN BASED ON A HIGH METER RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2813138

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| L| R