BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2922206 · Received January 18, 2013

    Report

    Report Number
    2531779-2013-00846
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 20, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. LOSS OF PRIME WARNINGS WERE FOUND IN THE PUMP HISTORY RELATED TO 'REPLACE CARTRIDGE' ALARMS WHEN THE PUMP WAS NOT PRIMED AFTERWARD. A REWIND, LOAD, AND PRIME WERE COMPLETED WITH NO ISSUES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS; NO LOSS OF PRIME WARNINGS WERE DUPLICATED DURING TESTING. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE PUMP EMITTED EMPTY CARTRIDGE WARNINGS. SINCE THE ALARMS OCCURRED, THE REPORTER STATED THAT THEY CHANGED THE CARTRIDGE AND INFUSION SET AND HAS NOT RECEIVED ANY OTHER ALARMS. THE REPORTER STATED THAT THE PATIENT EXPERIENCED AN ALTERATION IN BLOOD GLUCOSE (BG) LEVELS ON (B)(6) 2012 AT SCHOOL WITH THE GLUCOMETER READING HI WITH NO SIGNS AND SYMPTOMS. THE REPORTER STATED THAT THE PUMP HAS BEEN ALERTING THAT THE PUMP HAS LOST PRIME AND THERE WAS NO DELIVERY. CUSTOMER SUPPORT EDUCATED REPORTER THAT EMPTY CARTRIDGE ALERTS WILL POTENTIALLY CAUSE LOSS OF PRIME OR NO DELIVERY ALERTS UNTIL CARTRIDGE IS REPLACED. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT THAT RESULTED FROM AN INADEQUATE RESPONSE TO A PUMP ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27252 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening