BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3052647 · Received April 11, 2013

    Report

    Report Number
    3008382007-2013-07591
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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) 2013, THE LAY USER/PATIENT'S CAREGIVER (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE REPORTER ALLEGED THAT THE ISSUE FIRST BEGAN IN OCTOBER (YEAR NOT SPECIFIED). ON AN UNKNOWN DATE/TIME, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF "100, 144, 140, 134, 195, AND 101" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT'S DIABETES IS MANAGED WITH NOVOLOG (SLIDING SCALE) AND LANTUS (65 UNITS IN THE MORNING AND EVENING). ACCORDING TO THE REPORTER, IN RESPONSE TO THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY CONTINUED WITH HER USUAL DOSE OF MEDICATION (DATE/TIME NOT KNOWN). ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT'S BLOOD GLUCOSE REPORTEDLY "CRASH" DOWN AND ON SEVERAL OCCASIONS (DATES/TIMES UNKNOWN) HAD SYMPTOMS OF FAINTING AND TIRED. FOLLOWING THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY WAS HOSPITALIZED ON SEVERAL OCCASIONS (DATES NOT SPECIFIED) FOR HYPOGLYCEMIA AND HAD RECEIVED UNSPECIFIED TREATMENTS FOR LOW BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER AND NOTED THAT THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S MANUAL) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154515 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3378887

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R