BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1912654 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02532
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER (REPORTER) CONTACTED ANIMAS ON (B)(6) 2010 TO REPORT THE FOLLOWING: THE PATIENT HAS HAD HIGH BLOOD GLUCOSE LEVELS OVER THE PAST FEW WEEKS, BUT ALSO INDICATED THAT THE PATIENT BECAME SICK 2-3 WEEKS AGO WITH A COLD. ON (B)(6) 2010, THE PATIENT HAD BLOOD GLUCOSE LEVELS OVER 300 MG/DL WITH NO SYMPTOMS OF VOMITING, SHORTNESS OF BREATH, CHEST PAIN; HOWEVER, HE HAD STOMACH PAINS, MODERATE KETONES, AND LOW GRADE FEVER. THE PATIENT'S DOCTOR ADVISED THE REPORTER TO TREAT THE PATIENT WITH SYRINGE, WHICH LOWERED THE PATIENT'S BLOOD GLUCOSE. THE PATIENT ALSO CORRECTED HIS HIGH BLOOD GLUCOSE WITH THE PUMP. THE PATIENT DID NOT RECEIVE ANY OTHER FORMS OF MEDICAL INTERVENTION. ON AN UNSPECIFIED DATE, THE PATIENT BECAME HYPOGLYCEMIC WITH SYMPTOMS OF WEAKNESS AND SHAKING: THE PATIENT ADMINISTERED SELF-TREATMENT WITH FOOD AND/OR DRINK. THE ANIMAS REPRESENTATIVE WENT THROUGH TROUBLESHOOTING WITH THE REPORTER AND NOTED THE FOLLOWING: THERE WERE NO INFUSION SITE/SET ISSUES, THE INSULIN WAS WITHIN EXPIRATION DATE, THE TOTALS FOR THE BOLUS/BASAL IN THE PUMP HISTORY WAS CORRECT, AND THE PUMP SETTINGS WERE CONFIRMED TO BE CORRECT; HOWEVER, THE DATE/TIME SETTING WAS INCORRECT. ACCORDING TO THE PUMP HISTORY, IT APPEARS THAT THE LAST TIME THE PUMP HAD THE CORRECT DATE/TIME SETTING WAS ON (B)(6) 2010. SHE ADMITTED SHE HAD FORGOTTEN TO RESET THE DATE/TIME SETTINGS WHEN SHE REPLACED THE BATTERY. THE ANIMAS REPRESENTATIVE NOTED THAT THERE WAS NOTHING TO INDICATE A MECHANICAL PROBLEM WITH THE PUMP. THERE WAS NO INDICATION THAT THE PRODUCT MALFUNCTIONED; HOWEVER, THIS COMPLAINT IS STILL BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED HIGH BLOOD GLUCOSE WITH MODERATE KETONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention