BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2900211 · Received January 7, 2013

    Report

    Report Number
    3008382007-2013-00200
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    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
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/REPORTER, THE PATIENT'S DAUGHTER, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2012, THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 559 MG/DL, 525 MG/DL, 269 MG/DL AND 206 MG/DL ON THE REPORTED METER. THE PATIENT ALSO REPORTED READINGS TAKEN ON ANOTHER METER OVER A TIME PERIOD GREATER THAN 30 MINUTES OF 292 MG/DL AND 304 MG/DL. AT 2:00 PM, THE PATIENT TOOK AN INCREASED DOSE OF LANTUS INSULIN; THE SPECIFIC DOSE WAS NOT PROVIDED. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SWEATING, HEADACHE, CHEST PAIN, NAUSEA, IMPAIRED VISION AND DISORIENTATION. EMERGENCY SERVICES WERE CONTACTED; WHEN PARAMEDICS ARRIVED AT 2:30 PM THEY TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL USING THEIR METER TO BE 54 MG/DL. THE PATIENT WAS TREATED WITH FOOD AND DRINK. TROUBLESHOOTING REVEALED THE PATIENT HAD IMPROPERLY STORED THE TEST STRIPS OUTSIDE THEIR PROPER CONTAINER, WHICH CAN COMPROMISE THE INTEGRITY OF THE TEST STRIPS AND CAUSE INACCURATE READINGS. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT'S TECHNIQUE WAS INCORRECT BY STORING THE TEST STRIPS IMPROPERLY. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTERWARDS AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH FOOD, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6486 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R