BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3203190 · Received July 2, 2013

    Report

    Report Number
    3008382007-2013-18869
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 6, 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
    WI, 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 CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA2 METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT MANAGES HIS DIABETES WITH 70/30 INSULIN TAKEN ON A SLIDING SCALE. TWO DAYS AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF HEADACHE AND DIZZINESS. THE PATIENT WENT TO THE EMERGENCY ROOM WHERE HIS BLOOD GLUCOSE LEVEL WAS TESTED TO BE 300 MG/DL. THE PATIENT WAS TREATED WITH INSULIN. TROUBLESHOOTING REVEALED THE PATIENT¿S TEST STRIPS WERE CORRECT, AND THAT HE HAD NOT REPLACED THE METER¿S BATTERY AS RECOMMENDED BY THE MANUFACTURER. THE ISSUE WAS NOT RESOLVED AS THE PATIENT DID NOT HAVE A NEW REPLACEMENT BATTERY AVAILABLE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT'S TECHNIQUE WAS INCORRECT BY NOT REPLACING THE METER'S BATTERY AS RECOMMENDED. THE PATIENT ALLEGEDLY SUFFERED BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPERGLYCEMIA AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH INSULIN AFTER THE METER POWER ISSUE OCCURRED. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302127 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3378023

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R