BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2881630 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14897
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 16, 2012
    Report Date
    December 16, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4): DEVICE EVALUATION- A RESERVED SAMPLE FROM THE SAME CARTRIDGE LOT NUMBER B201795 WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION, A FORCE TEST AND A LEAK TEST OF THE CARTRIDGE WERE PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 STATING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 22MMOL/L WITH HIGH KETONES, FREQUENT URINATION, AND MOODINESS. THE REPORTER INDICATED THAT THE PATIENT WAS GIVEN A CORRECTION PER THE PUMP RECOMMENDATIONS AND THE PATIENT'S BLOOD GLUCOSE RESOLVED TO 10MMOL/L. THE PATIENT CONTINUED ON THE PUMP AND LATER IN THE DAY THE PATIENT WAS BACK UP TO 19MMOL/L. THE REPORTER STATED THAT THE PATIENT WAS RECEIVING MULTIPLE LOSS OF PRIME WARNINGS OFF AND ON FOR THE LAST COUPLE WEEKS, BUT THAT DAY WAS WORSE THAN THE OTHERS. THE PATIENT CONFIRMED NO KNOWN POWER LOSS, THE LEUR LOCK CONNECTION AND CARTRIDGE CAP WERE SECURE, THERE WERE NO CHANGES IN FORCE OR TEMPERATURE, NO RELEVANT ALARMS, AND NO UNINTENDED SUSPENDS. TROUBLESHOOTING OF THE CARTRIDGE FILLING TECHNIQUE FOUND THAT THE REPORTER WAS USING REFRIGERATED INSULIN IN THE CARTRIDGE. THE REPORTER WAS ADVISED TO TRY USING ROOM TEMPERATURE INSULIN TO SEE IF THE ISSUE PERSISTED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    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 7 YR Life Threatening