BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1933785 · Received December 15, 2010

    Report

    Report Number
    2531779-2010-02604
    Event Type
    Death
    Date Received
    December 15, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    OTP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN NO ALLEGATION OF PUMP MALFUNCTION OR DEFECT. THIS REPORT IS BEING SUBMITTED DUE TO THE PAUCITY OF EVIDENCE THAT WOULD RULE OUT THAT THE PUMP DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED AND/OR ADDITIONAL INFO COMES TO LIGHT, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT WAS FOUND IN A COMA AROUND (B)(6) 2010 AND SUBSEQUENTLY HOSPITALIZED FOR HYPERGLYCEMIA, CONGESTIVE HEART FAILURE, AND SEPSIS. WHEN THE PT WAS FOUND, THE PUMP WAS EMITTING AN EMPTY CARTRIDGE ALARM. AFTER HIS HOSPITALIZATION, THE PT RESTARTED PUMP THERAPY UNDER SUPERVISION FROM HEALTH CARE PROVIDERS AND USED IT WITHOUT SUBSEQUENT REPORTED EVENTS. THIS EVENT WAS REPORTED PREVIOUSLY (SEE MFR REPORT# 2531779-2010-00463). ON (B)(6) 2010 THE PT'S WIFE REQUESTED PUMP TRAINING FROM ANIMAS SO THAT SHE COULD MANAGE THE PT'S DIABETES. ON (B)(6) 2010 A HOSPITAL NURSE EXPLAINED THAT THE PT WAS HOSPITALIZED FOR A NON-DIABETES-RELATED ISSUE AND REQUESTED ASSISTANCE TURNING OFF THE PUMP. ON (B)(6) 2010 A BILLING STATEMENT WAS RETURNED TO ANIMAS FROM (B)(6) WITH A COMMENT SAYING THAT THE PT WAS DECEASED. AT THIS TIME, THERE IS NO FURTHER INFO ABOUT THE CAUSE OF HIS DEATH AND NO CONFIRMATION THAT HE WAS WEARING OR NOT WEARING THE PUMP. THERE HAS BEEN NO REPORT OF PUMP MALFUNCTION. THIS REPORT IS BEING SUBMITTED DUE TO THE PAUCITY OF EVIDENCE THAT WOULD RULE OUT THAT THE PUMP DID NOT CAUSE OF CONTRIBUTE TO THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death