BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2116802 · Received June 8, 2011

    Report

    Report Number
    2531779-2011-03993
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDITIONAL INFORMATION WAS NOT PROVIDED ON THE INITIAL REPORT: THE PATIENT'S MOTHER CALLED ANIMAS ON (B)(6) 2011 REPORTING THAT THE PUMP KEPT ALARMING THAT THE PUMP WAS NOT PRIMED. SHE SAID THE ISSUE STARTED ON (B)(6) 2011. THE MOTHER CONFIRMED THAT THE PATIENT WAS DISCONNECTED FROM THE INFUSION SET. SHE SAID THE BASAL RATE WAS CORRECT AS DISPLAYED ON THE VERIFY SCREEN. SHE SAYS THAT THE PUMP ONLY NEEDED TO BE REPRIMED AND NOT REBOOTED. THE PATIENT REPORTEDLY HAD A BLOOD GLUCOSE LEVEL OF 509 MG/DL DURING THIS TIME. THE PATIENT'S MOTHER DISCONTINUED PUMP THERAPY AND STARTED INJECTIONS. THE PATIENT'S BLOOD GLUCOSE LEVELS SUBSEQUENTLY RESOLVED TO 178 MG/DL. DURING TROUBLESHOOTING THE REPORTER WALKED THROUGH REWIND, LOAD, AND PRIME STEPS, AND AGAIN THE PUMP LOST PRIME. THE PUMP WAS REPORTEDLY NOT EXPOSED TO EXTREME TEMPERATURE CHANGES. THE REPORTER TRIED CARTRIDGES FROM ANOTHER BOX AND COMPLETED REWIND, LOAD, AND PRIME STEPS, AND AGAIN RECEIVED A LOSS OF PRIME ALARM. SHE CONFIRMED THAT THE CARTRIDGE CAP WAS TIGHT AND THERE WAS NO EXTREME CHANGE IN TEMPERATURE TO THE CARTRIDGES. THIS SITUATION IS REPORTED AS SUPPLEMENTAL INFORMATION AS THE PATIENT SUFFERED AN ELEVATED BLOOD GLUCOSE LEVEL WHILE THE PATIENT'S MOTHER WAS HAVING DIFFICULTY PRIMING THE PUMP.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS MISSING FROM THE INITIAL REPORT. CORRECTION 2531779-03/24/2010-003-R.

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/01/2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. DURING EVALUATION THE FORCE SENSOR FLEX CONNECTOR WAS FOUND TO BE DAMAGED AT THE FORCE SENSOR PINS.

    Description of Event or Problem · 1

    THE PUMP HAS BEEN RETURNED FOR MULTIPLE LOSS OF PRIME WARNINGS. EVALUATION REVEALED A DAMAGED FORCE SENSOR FLEX CONNECTOR. THIS REPORT IS BEING MADE BASED ON THE EVALUATION RESULTS.

    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| R