BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC ENHANCED METER

    MDR report key: 1060351 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01057
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 24, 2008
    Report Date
    May 27, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D 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 2008, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH BASIC METER WAS NOT POWERING ON. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON JUNE 10, 2008 AND OBTAINED THE FOLLOWING INFO. THE PT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN APPROX THREE DAYS PRIOR TO CONTACTING LFS. ON THREE DAYS PRIOR TO ORIGINAL DATE (TIME UNK), SOMETIME AFTER THE REPORTED ISSUE BEGAN, THE PT REPORTED FEELING "VERY DIZZY" AND THEN PASSING OUT. THE PT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE AT THE TIME OF THE SYMPTOMS BECAUSE THE SUBJECT METER WAS NOT WORKING AND HE DID NOT HAVE A BACKUP METER TO TEST WITH. EMERGENCY MEDICAL SVS (EMS) WAS CONTACTED AT THE TIME OF THIS INCIDENT. THE PT REPORTED HE WAS TESTED ON THE EMS METER, AND COULD ONLY CONFIRM THEY OBTAINED A LOW READING (RESULT UNK). AS A RESULT OF THE ALLEGED LOW READING, THE PT WAS REPORTEDLY TREATED WITH IV GLUCOSE AND TAKEN TO THE ER. THE PT REPORTED STAYING IN THE ER FOR ABOUT ONE DAY AND THEN BEING DISCHARGED. AT THE TIME OF TROUBLESHOOTING WITH THE CUSTOMER CARE ADVOCATE (CCA), THE PT WAS UNABLE/UNWILLING TO REPORT THE FOLLOWING: IF THE BATTERY WAS INSTALLED CORRECTLY, THE CONDITION OF THE BATTERY CONTACTS, IF THERE WAS MISUSE OF THE METER, AND IF THE BATTERY WAS REPLACED PER THE OWNER'S MANUAL. REPLACEMENT PRODS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE AND REPORTEDLY HAD TO RECEIVE TREATMENT FROM A HCP FOR SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R