BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2803491 · Received October 24, 2012

    Report

    Report Number
    2531779-2012-12690
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201855 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    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 MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO MAKE SURE HIS ANIMAS INSULIN PUMP IS WORKING ACCORDINGLY PER THE DOCTOR'S REQUEST. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND WAS TREATED FOR DKA AND UNEXPLAINED 545 MG/DL ON (B)(6) 2012. AT THE TIME OF CONCERN, THE PATIENT WAS TAKEN OFF OF INSULIN PUMP THERAPY AND PLACED ON INSULIN DRIP AT 5 UNITS PER HOUR IN THE ICU. DURING THE REVIEW OF THE ANIMAS INSULIN PUMP, THE HISTORY SHOWED THE PATIENT RECEIVED SEVERAL WARNINGS INCLUDING "PUMP IS NOT PRIMED," EMPTY CARTRIDGE, AND BATTERY ALARMS. IT WAS NOTED THAT THERE WAS NO RECORD OF THE PUMP WAS PRIMED AFTER THE BATTERY AND CARTRIDGE REPLACEMENT ON THE DAY OF CONCERN PRIOR TO THE PATIENT'S HOSPITALIZATION. THE PATIENT RESUMED INSULIN PUMP THERAPY AT 11 AM ON THE DAY OF THE CALL TO ANIMAS. THERE WAS NO PRODUCT MISUSE. THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTIONED ASSOCIATED WITH THE ALLEGED INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REQUIRED MEDICAL INTERVENTION FOR DKA WHILE ON INSULIN PUMP THERAPY. IT IS NOT CLEAR WHETHER DIABETES MANAGEMENT, USE ERROR, OR INTENTIONAL MISUSE WAS INVOLVED THE ALLEGED INCIDENT.

    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 22 YR Hospitalization| L| R