BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1033890 · Received April 25, 2008

    Report

    Report Number
    2939301-2008-00619
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 EVAL, 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

    IN 2008, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER WAS READING INACCURATELY. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE TO THE PT ON ELEVEN DAYS LATER, AND WAS ABLE TO OBTAIN/VERIFY LIMITED INFO. THE PT TESTS HIS BLOOD GLUCOSE 4-5 TIMES A DAY. HE TAKES SLIDING-SCALE HUMALOG INSULIN BASED ON HIS METER READINGS. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON SIX DAYS PRIOR TO ORIGINAL DATE. THE PT MENTIONED THAT HE HAD BEEN HAVING "HIGH BLOOD SUGARS" AND 'LOW BLOOD SUGARS" AS A RESULT OF THE METER. HE ALSO STATED THAT HIS NUMBERS HAVE BEEN "UP AND DOWN" AND WERE "WAY OFF." THE PT ALSO SAID THAT HE WOULD TAKE 5 READINGS IN A ROW AND ALL THE RESULTS WOULD BE DIFFERENT. THE PT CLAIMED THAT HE PASSED OUT IN THE EARLY MORNING HRS OF EARLY IN THE ORIGINAL MONTH. HE FELT AS THOUGH HE WAS NOT GIVING HIMSELF THE RIGHT AMOUNTS OF MEDICATIONS BECAUSE OF THE METER'S INACCURACY ISSUE. DURING EACH EVENT, THE PT SAID THAT THE PARAMEDICS WERE CONTACTED AND HE WAS TAKEN TO A HOSP FOR TREATMENT OF LOW BLOOD SUGARS. HE WAS UNABLE TO SPECIFY WHAT EXACT TREATMENT HE RECEIVED. THE PT OBTAINS BLOOD SAMPLES FROM HIS FINGERS AND CLEANS 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 HE PASSED OUT AND RECEIVED MEDICAL TREATMENT FOR HYPOGLYCEMIA 3 TIMES AFTER THE ALLEGED METER INACCURACY ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R