BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2132663 · Received June 17, 2011

    Report

    Report Number
    2531779-2011-04249
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED THAT LOSS OF PRIME WARNINGS ASSOCIATED WITH LOW NON-ZERO FORCE WERE OBSERVED INDICATING THAT THE PUMP WAS ALARMING APPROPRIATELY. LOW AND REPLACE CARTRIDGE ALARMS WERE OBSERVED IN THE HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY LOSS OF PRIME WARNINGS BEING DUPLICATED. A REVIEW OF THE PUMP DEVICE HISTORY RECORD SHOWED THAT THE PUMP WAS PERFORMING ACCORDING TO SPECIFICATIONS AT THE TIME OF RELEASE. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF ABOUT 60, WHICH WAS TREATED BY THE PATIENT'S SCHOOL. THE FAMILY MEMBER REPORTED THAT SHE DID NOT KNOW SHE WAS SUPPOSED TO SKIP THE FILL CANNULA STEP WHEN REPRIMING. THE FAMILY MEMBER STATED THAT THE PUMP HAD LOST PRIME SEVEN TIMES ON THE DAY OF THE INCIDENT AND THE PATIENT DID THE FILL CANNULA STEP WITH EACH LOSS OF PRIME WARNING, CAUSING INADVERTENT INFUSION OF INSULIN. THE FAMILY MEMBER FELT THAT THIS WAS THE REASON FOR THE LOW BLOOD GLUCOSE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA AFTER INADVERTENTLY INFUSING INSULIN.

    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 9 YR Required Intervention