BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070833 · Received April 15, 2011

    Report

    Report Number
    2531779-2011-02655
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Report Date
    March 20, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT'S MOTHER CONTACTED ANIMAS ALLEGING THE PATIENT HAS HAD ELEVATED BLOOD GLUCOSE (BG) READINGS SINCE (B)(6) 2011. THE REPORTER CLAIMED THE PATIENT WAS TESTING AT 250, 264, AND 280 MG/DL. THE PATIENT'S MOTHER DENIED THAT THE PATIENT DEVELOPED SYMPTOMS ASSOCIATED WITH A HIGH BG AND CONFIRMED SHE TESTED NEGATIVE FOR KETONES. THE PATIENT'S REPORTED BG READINGS DO NOT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY. DURING TROUBLESHOOTING, THE PATIENT'S MOTHER REPORTED THAT SHE FILLED THE CARTRIDGE WITH 140 UNITS OF INSULIN ON (B)(6) 2011 AND ON THE FOLLOWING DAY, SHE RECEIVED A LOW CARTRIDGE WARNING. THE REPORTER STATED THAT THE LOW CARTRIDGE WARNING IS SET TO 20 UNITS AND WHEN SHE REMOVED THE CARTRIDGE, SHE CONFIRMED IT ONLY HAD 20 UNITS OF INSULIN LEFT IN IT. THE REPORTER WAS CONCERNED THERE MAY BE A PROBLEM WITH DEVICE SINCE THE PATIENT DID NOT USE 140 UNITS OF INSULIN SINCE THE TIME THE CARTRIDGE WAS REPLACED. DURING REVIEW OF PUMP'S HISTORY, TDD FOR (B)(6) 2011 SHOWED 29.19 UNITS AND TDD FOR (B)(6) 2011 WAS 32 UNITS. PRIME HISTORY REVEALED 15 UNITS WERE USED ON (B)(6) 2011 FOR PRIMING (INCLUDES CANNULA FILL). DURING REVIEW OF PUMP HISTORY, IT WAS CONFIRMED THAT BASAL SETTING AND TDD BASAL HISTORY MATCHED. THE REPORTER CONFIRMED THERE WERE NO SIGNS OF INSULIN LEAKING AT THE SITE OR BENDING OF THE CANNULA. THE PATIENT'S MOTHER ALSO CONFIRMED THERE WERE NO SIGNS OF CARTRIDGE LEAKING AND THAT THE PUMP'S CARTRIDGE COMPARTMENT WAS DRY. THE REPORTER WAS UNABLE TO DETECT WHERE EXCESS INSULIN HAD GONE.

    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