BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1243813 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03223
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 17, 2008
    Report Date
    November 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SENIOR MEDICAL AFFAIRS SPECIALIST OBTAINED AND CLARIFIED INFORMATION FROM THE PATIENT/LAYPERSON ON 11/20/08. CUSTOMER SERVICE HAD REPLACED THE METER AND TEST STRIPS WHEN UNABLE TO RESOLVE THE ALLEGED ISSUE. THE PATIENT ALLEGED THE FOLLOWING: THE PATIENT'S ONETOUCH ULTRALINK METER WOULD NOT COUNTDOWN AFTER HE APPLIED BLOOD TO TEST STRIPS MULTIPLE ATTEMPTS FOUR DAYS PRIOR. THE PATIENT WAS UNABLE TO OBTAIN RESULTS THE ENTIRE DAY AND EVENING. AROUND 3A.M. ON THE NEXT DAY, THE PATIENT'S INSULIN PUMP AUTOMATICALLY TURNED OFF, SIGNALING HIM THAT HIS BLOOD GLUCOSE WAS BELOW A CERTAIN LEVEL. THE PATIENT BOLUSED ONE UNIT OF INSULIN TO START THE PUMP; HE STATED THAT HE DID NOT REALIZE ONE COULD TURN THE PUMP ON WITHOUT BOLUSING. THE PATIENT FELL BACK TO SLEEP AND AROUND 6A.M. HIS SON HEARD HIM "ROLL" OUT OF BED AND FOUND THE PATIENT REPORTEDLY INCOHERENT, SHAKY, COMBATIVE, AND IN A COLD SWEAT. EMERGENCY MEDICAL WAS CALLED, OBTAINING "128" MG/DL ON THE ACCUCHECK METER. DUE TO THE RESULT, EMT TRANSPORTED THE PATIENT TO THE ER RATHER THAN TREAT HIM. AFTER THE ER METER'S OWN ACCUCHECK RESULT OF "42", THE PATIENT WAS TREATED WITH ONE D50 AMPULE BY IV. AFTER FOUR HOURS IN ER, HE WAS DISCHARGED. IT IS UNCLEAR WHY THE PATIENT ELECTED TO TURN THE PUMP BACK ON BY BOLUSING ADDITIONAL INSULIN SINCE THE PUMP'S FEATURE WARNED HIM HIS BLOOD GLUCOSE WAS LOW. THE PATIENT ALLEGED THAT HE COULD HAVE SELF TREATED IF HE HAD KNOWN HIS BLOOD GLUCOSE LEVEL. IN ADDITION, THE PATIENT REPORTEDLY HAD TO BE TREATED AT THE ER AFTER THE REPORTED ISSUE. THEREFORE, THE COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2861174

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R