BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2679604 · Received August 2, 2012

    Report

    Report Number
    2531779-2012-07576
    Event Type
    Injury
    Date Received
    August 2, 2012
    Report Date
    July 6, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CLAIMED THE ANIMAS HAS HAD A CRACKED IN THE PUMP CASING NEAR THE CARTRIDGE CAP FOR THE PAST 6 MONTHS. THE PATIENT REPORTEDLY HAS HAD OCCASIONAL LOSS OF PRIME ALARMS POSSIBLY DUE TO A LOOSE CARTRIDGE CAP ISSUE. THE REPORTER CLAIMED THAT AS THE CRACK GETS BIGGER, THE LOSS OF PRIME ALARMS IS MORE FREQUENT. THE REPORTER FELT THAT THE LOSS OF PRIME MESSAGE IS RELATED TO THE PATIENT'S OCCASIONAL UNEXPLAINED HIGH BLOOD GLUCOSE OVER THE PAST 3-4 WEEKS. REPORTEDLY, THE PATIENT'S BLOOD GLUCOSE READING HAS VARIED FROM 250-514 MG/DL. THERE WAS NO SYMPTOM OR SIGN RELATED WITH THE ALLEGED HIGH BLOOD GLUCOSE READING. DURING TROUBLESHOOTING, THE REPORTER DENIED ANY ISSUES WITH SUPPLIES OR SITES. THERE WAS PRODUCT MISUSE. THE PRODUCT WAS REPLACED DUE TO THE DAMAGE CASING. IT WAS UNCLEAR HOW THE LOSS OF PRIME ALARMS ATTRIBUTED TO THE PATIENT'S ELEVATED BLOOD GLUCOSE. THE PRODUCT WAS REQUESTED BACK TO ANIMAS FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT HAD BLOOD GLUCOSE OVER 500 MG/DL AFTER THE CRACKED CASING ISSUE BEGAN.

    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 10 YR Life Threatening