BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1151413 · Received September 4, 2008

    Report

    Report Number
    2939301-2008-01996
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 26, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PROD FOR EVAL, BUT HAS NOT YET REC'D IT. IF THE LFS PROD IS RETURNED, LIFESCAN WILL EVALUATE IT, AND IF THE LFS PROD DOES 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 (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING INACCURATE LOW READINGS. ON THE FOLLOWING MONTH, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT TO CLARIFY INFO OBTAINED FROM THE INITIAL CALL. ACCORDING TO THE PT, HE FIRST NOTICED THAT THE SUBJECT METER HAD BEEN GIVING HIM LOW READINGS FOR THE LAST COUPLE OF WEEKS. THE PT INDICATED THAT HE HAS BEEN ON A GLUTEN FREE PASTA DIET, WHICH HE THOUGHT WAS LOWERING HIS BLOOD GLUCOSE. THE PT DID NOT HAVE ANY SYMPTOMS WHILE HE OBTAINED THE LOW READINGS DURING THE WEEKS IN QUESTION. WHEN THE PT CONSULTED WITH THE DR AND REPORTED THE LOW READINGS HE HAD BEEN OBTAINING ON THE SUBJECT METER, THE DR ADVISED HIM TO STOP TAKING HIS METFORMIN MEDICATION. HOWEVER, AFTER HE STOPPED TAKING HIS DIABETES MEDICATION FOR AN UNSPECIFIED PERIOD OF TIME, THE PT REPORTEDLY STARTED TO DEVELOP SYMPTOMS OF FREQUENT URINATION. THE PT WAS GOING TO THE BATHROOM EVERY HOUR. THE PT COULD NOT SPECIFY THE LFS METER READINGS PRIOR TO THE ONSET OF THE REPORTED SYMPTOMS. WHILE THE PT HAD THE AFOREMENTIONED SYMPTOMS, HE INDICATED THAT HE WAS OBTAINING BLOOD GLUCOSE READINGS OF "103, 83 AND 73 MG/DL" ON THE SUBJECT METER. WHEN THE PT COMPARED HIS BLOOD GLUCOSE READING TO AN OLD METER HE PREVIOUSLY USED, HE REPORTED BLOOD GLUCOSE RESULTS OF "98 MG/DL" WITH A LIFESCAN METER AND "160 MG/DL" ON ANOTHER METER, 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 PT REPORTEDLY STARTED TO TAKE HIS DIABETES MEDICATION AGAIN AND THE AFOREMENTIONED SYMPTOMS ABATED WITHIN 2 DAYS. THE PT REPORTEDLY FELT THAT THE METER WAS GIVING INACCURATELY LOW READINGS BECAUSE THE SUBJECT WAS NOT CODED CORRECTLY. THE PT CONTINUES TO TAKE HIS DIABETES MEDICATION OF METFORMIN DAILY AND TESTS HIS BLOOD GLUCOSE AS USUAL. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. HOWEVER, IT NOTED THAT THE SUBJECT METER WAS NOT CODED CORRECTLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT HE STOPPED TAKING HIS MEDICATION AFTER HE OBTAINED LOW READINGS ON THE SUBJECT METER, AND DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPERGLYCEMIA. REPLACEMENT PRODS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2835747

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R