BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2070215 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02914
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THERE ARE NO ALARMS RELATED TO THE COMPLAINT IN THE ALARM HISTORY. A REVIEW OF THE BLACK BOX SHOWED TYPICAL USAGE ALARMS AND WARNINGS OCCURRING; THE PUMP WAS USED AFTER THE INITIAL COMPLAINT DATE OF (B)(6) 2011; THE BLACK BOX AND TOTAL DAILY DELIVERY HISTORIES FROM THE TIME OF THE EVENT WERE OVERWRITTEN. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING INSULIN WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE KEYPAD WAS FOUND TO BE TORN; ALL BUTTONS WERE FOUND TO BE RESPONSIVE, THIS ISSUE HAS NO EFFECT ON INSULIN DELIVERY FUNCTION.

    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. THE PATIENT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. 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. 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 THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) OF 464 MG/DL WITH THE PRESENCE OF HIGH KETONES AND WENT TO THE EMERGENCY ROOM (ER) FOR TREATMENT. A FAMILY MEMBER STATED THAT PRIOR TO THE HOSPITALIZATION THE PUMP ALARMED WITH AN OCCLUSION; SHE REPORTED A BENT CANNULA AND BLOOD IN THE CANNULA; THE PATIENT REPLACED THE INFUSION SET BUT BG REMAINED ELEVATED. THE FAMILY MEMBER SAID THAT THE PATIENT RECEIVED A CORRECTION DELIVERY OF INSULIN VIA SYRINGE PRIOR TO GOING TO THE ER; THE BG INCREASED AFTER THE MANUAL CORRECTION. ONCE IN THE ER, THE PATIENT RECEIVED FLUIDS AND CONTINUED TO USE THE PUMP FOR INSULIN DELIVERY. HIS BG WAS ABOUT 240MG/DL WHEN THE PATIENT WAS DISCHARGED. THE FAMILY MEMBER REPORTED THAT THE NEXT DAY THE PATIENT'S BG RANGED FROM 63 MG/DL TO 521 MG/DL; THERE WERE NO REPORTED SYMPTOMS AND KETONES WERE NOT TESTED. THE FAMILY MEMBER DENIED ANY FURTHER ISSUES WITH THE INFUSION SITE, NO LEAKAGE OR AIR BUBBLES IN THE CARTRIDGE, AND NO PRIMING DIFFICULTIES. THE BASAL RATES AND BOLUS SETTINGS WERE CORRECTLY PROGRAMMED; THE TIME AND DATE WERE CORRECT; THERE WERE NO PUMP SUSPENSIONS OR TEMPORARY BASAL RATES; AND DIET AND ACTIVITY LEVELS WERE UNCHANGED. BASAL AND BOLUS DELIVERIES WERE ACCURATE. CUSTOMER SUPPORT CONCLUDED THAT THERE WERE NO APPARENT MALFUNCTIONS OR DELIVERY ISSUES; THEY ADVISED THE FAMILY MEMBER TO SEEK ASSISTANCE FROM THE PATIENT'S HEALTH CARE PROVIDERS TO ADDRESS THE EFFECTS OF PUBERTY AND CELIAC DISEASE ON THE PATIENT'S INSULIN NEEDS. THE COMPLAINT IS BEING REPORTED BECAUSE OF THE CHANCE THAT USER ERROR CONTRIBUTED TO THE BG EXCURSION.

    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 Hospitalization