BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2003130 · Received February 28, 2011

    Report

    Report Number
    2939301-2011-01653
    Event Type
    Injury
    Date Received
    February 28, 2011
    Report Date
    February 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO FEELING/NORMAL RESULT(S). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN BETWEEN (B)(6) 2010 AND (B)(6) 2011 PRIOR TO CONTACTING LFS. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "313, 404, 249, 414, 249, 362, 351, AND 411 MG/DL" WITH THE SUBJECT METER. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN 1000MG) AND INSULIN (NOVOLOG 70/30). THE PATIENT MENTIONED SHE TAKES 1-2 TABLETS OF METFORMIN DAILY AND INJECTS 60 UNITS IN THE MORNING AND 35 UNITS IN THE EVENING OF NOVOLOG. DUE TO THE ALLEGED HIGH READINGS, THE PATIENT INDICATED SHE INCREASED HER DOSE OF INSULIN TO 30 UNITS AND SKIPPED HER DOSE OF ORAL MEDICATION BETWEEN DECEMBER 2010 AND JANUARY 2011. AT AN UNSPECIFIED DATE/TIME, THE PATIENT INDICATED SHE DEVELOPED SYMPTOMS OF HEART PALPITATION AND BECAME JITTERY, NERVOUS, SLUGGISH, TIRED, AND HAD NO ENERGY AFTER THE ALLEGED ISSUE BEGAN. SOMETIME BETWEEN (B)(6) 2010 AND (B)(6) 2011 AT 7:00PM, THE PATIENT REPORTEDLY WAS ADMITTED TO THE EMERGENCY ROOM (ER). ACCORDING TO THE PATIENT, SHE WAS TESTED BY THE ER/HOSPITAL METER WITH A "91 MG/DL" READING AND WAS ADMINISTERED IV GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY. THE PATIENT STATED SHE DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3043137

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R