BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1944345 · Received December 15, 2010

    Report

    Report Number
    2531779-2010-02907
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/26/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DATA BEGINS ON (B)(6) 2014. THE BLACK BOX DATA AND PUMP HISTORIES FROM THE TIME OF THE ALLEGED INCIDENT WERE UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. A REVIEW OF THE AVAILABLE PUMP HISTORIES DID NOT FIND ANY ERRORS, ALARMS, OR WARNINGS ASSOCIATED WITH THE COMPLAINT. A REVIEW OF THE CURRENT TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO ANIMAS FOR EVAL. THE ANIMAS CDE INVOLVED WITH THE CONTACT WITH THE REPORTER DETERMINED THAT THE PUMP WAS FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6), 2010, ALLEGING A LOSS OF PRIME ISSUE WITH A PUMP. THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PT) WHO IS A CHILD. WHEN REPORTER CLAIMED THAT THE PT WAS AT A DAYCARE CENTER WHEN THE DEVICE ALARMED "PUMP NOT PRIMED, NO DELIVERY." THE REPORTER WENT TO THE DAYCARE CENTER AND NOTICED THAT THERE WAS NO INSULIN LEFT IN THE CARTRIDGE. THE REPORTER CLAIMED THAT THE CARTRIDGE SHOULD NOT HAVE BEEN EMPTY AT THE TIME. A REVIEW OF THE PRIME HISTORY REVEALED PRIMES OF "85.4 UNITS" AND "0.60 UNITS." THE REPORTER CLAIMED THAT ONLY 20 UNITS REMAINED IN THE CARTRIDGE PRIOR TO GOING TO DAYCARE. SHE BELIEVED THAT THE PT RECEIVED EXTRA INSULIN SINCE THE PT'S BLOOD GLUCOSE LEVEL DROPPED TO "37 MG/DL" SOON AFTER THE LOSS OF PRIME. THE PT WAS TREATED WITH JUICE AND OTHER FOOD. THE REPORTER BELIEVED THAT THE PT WAS PLAYING WITH THE PUMP AND MOST LIKELY PRESSED BUTTONS. THE REPORTER ALSO BELIEVED THAT THE PT REMOVED THE CARTRIDGE, PLAYED WITH THE CARTRIDGE, AND BUTTON PRESSED WHICH LED TO REWINDING/LOADING/AND PRIMING ON HER OWN. THE REPORTER ADMITTED THAT THE PT KNEW HOW TO UNLOCK THE PUMP. THE ANIMAS CDE INFORMED THE REPORTER THAT THE LOSS OF PRIME WAS DUE TO THE EMPTY CARTRIDGE. NO OTHER ALARMS WERE NOTED IN THE ALARM HISTORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Life Threatening