BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3873450 · Received June 14, 2014

    Report

    Report Number
    2939301-2014-14428
    Event Type
    Injury
    Date Received
    June 14, 2014
    Report Date
    June 6, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING AN ERROR 4 ISSUE AND A ¿CR 4¿ MESSAGE. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ACCORDING TO THE PATIENT, SHE HAD SOME EYE SIGHT ISSUE PRIOR TO THE ONSET OF THE ERROR 4 ISSUE AND ¿CR 4¿ MESSAGE. ON THE DAY THE REPORT ISSUE BEGAN, THE PATIENT REPORTEDLY WENT FOR A DOCTOR¿S OFFICE VISIT. SHE REPORTEDLY RECEIVED HCP TREATMENT WITH INSULIN TREATMENT (20 UNITS OF APIDRIA EVERY HOUR FOR 6 HOURS). THE PATIENT¿S MEDICATION OF APIDRA AND SOLOSTAR WAS INCREASED TO MANAGE HER DIABETES THAT DAY. IT WOULD HAVE BEEN HELPFUL TO OBTAIN MORE INFORMATION SURROUNDING THE ALLEGED REQUIRED HCP TREATMENT; HOWEVER, THE PATIENT WAS NOT AVAILABLE FOR FOLLOW-UP INFORMATION. THE ERROR 4 ISSUE AND ¿CR 4¿ MESSAGE WAS NOT RESOLVED WITH TRAINING. THE TEST STRIPS WERE WITHIN THE DISCARD DATE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REQUIRED INSULIN TREATMENT SUGGESTIVE FOR HYPERGLYCEMIA. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351784 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3545265

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention