BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2974382 · Received February 22, 2013

    Report

    Report Number
    2531779-2013-02038
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS ¿NO DELIVERY, EXCEEDS TDD¿ WARNING ON (B)(4) 2013. THE BLACK BOX SHOWED THAT THE TIME AND DATE HAD RESET TO DEFAULT SETTINGS AFTER A REBOOT AT 3:57PM ON (B)(4) 2013; THE TIME WAS THEN MANUALLY SET TO 4:30AM ON THE SAME DATE. DAILY INSULIN DELIVERY TOTALS APPEAR INCONSISTENT DUE TO THE TIME AND DATE ISSUE. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP PASSED FLOW ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    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. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (INADEQUATE RESPONSE TO AN ALARM).

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING RECEIVING A PUMP EXCEEDS MAXIMUM TOTAL DAILY DOSE ALARM AT 11:30PM ON (B)(6) 2013. THE PATIENT REPORTED THAT HE CONTINUED TO RECEIVE THE ALARMS DURING THE NIGHT AND HE WOULD JUST CONFIRM THEM AND GO BACK TO BED. THE PATIENT STATED HE DID NOT KNOW WHAT THE ALARM MEANT AND DID NOT TELL HIS MOTHER UNTIL THE MORNING. THE PATIENT NOTICED AT 6AM ON (B)(6) 2013 THAT THE TIME AND DATE WERE WRONG ON THE PUMP. THE PATIENT HAD CHANGED THE BATTERY AT 03:57PM ON (B)(6) 2013 AND THE PUMP TIME AND DATE REVERTED TO FACTORY DEFAULT SETTINGS. THE PATIENT DID NOT CORRECTLY FIX THE TIME AND DATE. THE PATIENT WOKE UP WITH A BLOOD GLUCOSE (BG) OF 405MG/DL WITH KETONES, MILD THIRST AND FEELS TIRED. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S HYPERGLYCEMIC EVENT RELATED TO AN INADEQUATE RESPONSE TO A PUMP ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78187 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening