BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SURESTEP ENHANCED METER

    MDR report key: 2220915 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07934
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    June 7, 2011
    Report Date
    August 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    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. THE 510(K) # IS K022724.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH SURESTEP METER'S DISPLAY WAS FADING AND IT DID NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT STATED THE ALLEGED ISSUES BEGAN APPROXIMATELY 7-8 MONTHS AGO, ALTHOUGH EXACT DATES/TIMES WERE NOT RECALLED. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH FIXED AMOUNTS OF LANTUS AND NOVOLOG INSULIN AND CLAIMED THAT WHEN SHE WAS UNABLE TO USE THE SUBJECT METER, SHE CONTINUED WITH HER USUAL DOSE OF MEDICATION. THE PATIENT CLAIMED THAT APPROXIMATELY TWO MONTHS AGO SHE BEGAN TO EXPERIENCE "PAIN IN HER KIDNEYS AND BLURRED VISION." SHE REPORTEDLY WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2011 AT 6PM AND WAS TESTED ON THE ER METER WHICH GAVE A READING OF "299 MG/DL." THE PATIENT DENIED RECEIVING ANY FORM OF TREATMENT BY THE HCP. THE PATIENT CLAIMED THESE SAME SYMPTOMS OCCURRED ON (B)(6) 2011 AT 2AM ALSO. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT DID NOT HAVE ANY TEST STRIPS. THERE WAS NO MISUSE OF THE PRODUCT AND THE ISSUE REMAINED UNRESOLVED. THE CCA PROVIDED AN UPGRADE TO A CURRENT BLOOD GLUCOSE MONITORING SYSTEM. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUES AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SURESTEP ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening