BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2083435 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03302
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. UPON EXAMINATION THERE WAS EVIDENCE OF MOISTURE INGRESS INTO THE BATTERY COMPARTMENT. INVESTIGATION CONFIRMED A DISPLAY LENS LEAK WITH EVIDENCE OF INTERNAL MOISTURE INGRESS. DURING TESTING, THE PUMP WOULD NOT POWER ON. THE BLACK BOX AND PUMP HISTORY WERE THEREFORE NOT AVAILABLE FOR EXAMINATION. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SWIM PRACTICE THE PATIENT EXPERIENCED ABDOMINAL PAIN WITH SHORTNESS OF BREATH; HER BLOOD GLUCOSE (BG) METER DISPLAYED "HI" AFTER BG WAS TESTED. A FAMILY MEMBER SAID THAT SHE TREATED THE PATIENT WITH A CORRECTION BOLUS VIA SYRINGE, THE BG RESOLVED TO 392 MG/DL AND THEN TO 110 MG/DL, AND THE SYMPTOMS DISAPPEARED. NO MEDICAL INTERVENTION WAS SOUGHT. THE FAMILY MEMBER REPORTED THAT SHE NOTICED THAT THE PUMP HAD LOST POWER AND SHE OBSERVED WATER UNDER THE LCD SCREEN AND IN THE BATTERY COMPARTMENT. SHE STATED THAT THE BATTERY CAP WAS REPLACED EVERY THREE MONTHS DUE TO THE PATIENT SWIMMING 6 TO 7 DAYS PER WEEK WITH THE PUMP. THE FAMILY MEMBER STATED THAT THE BATTERY CAP WAS ALWAYS SECURE AND THE O-RING WAS NOT VISIBLE, THE KEYPAD WAS INTACT, THE BATTERY COMPARTMENT WAS NOT CRACKED OR DAMAGED, AND THERE WAS NO KNOWN TRAUMA TO THE PUMP. WHEN SHE REINSERTED THE BATTERY INTO THE PUMP, IT VIBRATED CONTINUOUSLY AND THE SCREEN WAS BLANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening