BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1000996 · Received February 19, 2008

    Report

    Report Number
    2939301-2008-00198
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVAL, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVAL IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008 AT 1:54 PM (PST), THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY-USER/PT ALLEGING THAT ONE TOUCH ULTRA METER HAS A POWER ISSUE (METER DOES NOT TURN ON). AFTER THE REPORTED ISSUE BEGAN ON THE SAME DAY AT 3 PM (EST), THE PT REPORTED DEVELOPED SYMPTOMS DESCRIBED AS "SHAKINESS." THE PT WAS NOT TESTED ON ANY OTHER METER AND DENIED RECEIVING MEDICAL INTERVENTION. THE PT DID NOT TAKE ANY ACTION IN REGARDS TO DIABETES TREATMENT AS A RESULT OF THE REPORTED ISSUE. IT WOULD HAVE BEEN HELPFUL TO OBTAIN THE FOLLOWING INFO: TESTING FREQUENCY, DIABETES MEDICATION REGIMEN, FOOD INTAKE, DIABETES MEDICATION INTAKE, AND LFS METER READINGS PRIOR TO THE SYMPTOMS. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE METER DID NOT TURN ON WITH THE POWER BUTTON PRESSED AND THE TEST STRIP INSERTED INTO THE METER, THE BATTERY WAS NOT REPLACED PER THE OWNER'S MANUAL, THERE WAS NO PRODUCT MISUSED, AND THE BATTERY CONTACTS WERE IN GOOD CONDITION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT SHE EXPERIENCED SYMPTOMS THAT CAN BE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2749941

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Life Threatening