BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 771190 · Received October 17, 2006

    Report

    Report Number
    2939301-2006-01445
    Event Type
    Injury
    Date Received
    October 17, 2006
    Date of Event
    October 4, 2006
    Report Date
    October 4, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    na
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED 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 FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2006, THE LAY PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONE TOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST (MAS) SENT A LETTER TO THE PATIENT BECAUSE SHE COULD NOT BE REACHED BY PHONE WITH THE ASSISTANCE OF A SPANISH-SPEAKING INTERPRETER. THE FOLLOWING INFORMATION WAS PROVIDED DURING THE INITIAL CALL TO LFS: THE PATIENT OBTAINED A RESULT OF 440 MG/DL ON THE REPORTED METER WHILE HAVING NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVEL. SHE TOOK 15 UNITS OF REGULAR INSULIN AFTER USE OF THE METER PRIOR TO THE EVENT DATE, AT 12:37 AM. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT'S DIABETES MEDICATION AND DIET REGIMEN. AT AN UNSPECIFIED TIME AFTER TAKING THE INSULIN, THE PATIENT STATES HER BLOOD GLUCOSE LEVEL DROPPED AND PARAMEDICS WERE CALLED. SYMPTOMS AT THE TIME OF CONCERN WERE NOT PROVIDED. A RESULT OF 20 MG/DL WAS OBTAINED ON THE EMS METER. NO READING WAS OBTAINED ON THE REPORTED METER AT THE TIME EMS WAS SUMMONED. NO INFORMATION WAS PROVIDED REGARDING TREATMENT ADMINISTERED BY THE PARAMEDICS OR WHETHER THE PATIENT WAS TAKEN TO THE HOSPITAL. THE PATIENT CALLED LFS ON THE SAME DAY, AT 10:30 AM (PACIFIC TIME); IT APPEARS THAT EMS WAS ALSO SUMMONED PRIOR TO THE SAME DAY, AFTER THE PATIENT TOOK THE ABOVE REFERENCED INSULIN AND BEFORE SHE CALLED LFS. THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED THE PATIENT'S TESTING TECHNIQUES WAS CORRECT. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE CONTROL SOLUTION. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE PATIENT TOOK INSULIN APPARENTLY BASED ON THE READING OBTAINED ON THE LFS PRODUCT. SUBSEQUENTLY, ON THE SAME DAY, PARAMEDICS WERE SUMMONED AND OBTAINED A HYPOGLYCEMIC READING ON THE EMS METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2636247

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening