BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2914177 · Received January 14, 2013

    Report

    Report Number
    2531779-2013-00614
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION: (B)(6) 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 BLACK BOX FOR (B)(6) 2012, SHOWS THAT AT 6:56AM THE REMAINING INSULIN READING WAS 145UNITS; AT 6:59AM A "PUMP NOT PRIMED" WARNING WAS EMITTED FOLLOWED BY A 144.9UNIT PRIME; AT 7:41AM THE REMAINING INSULIN READING WAS 166UNITS; AT 7:44AM A "PUMP NOT PRIMED" WARNING WAS EMITTED FOLLOWED BY TWO PRIMES TOTALING 165.4UNITS. A REVIEW OF THE PRIME HISTORY VERIFIED THE REPORTED PRIME VOLUMES. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. REWIND, LOAD, AND PRIME STEPS WERE SUCCESSFULLY PERFORMED WITH NO ALARMS OCCURRING. THE FORCE SENSOR CALIBRATION WAS FOUND T BE WITHIN SPECIFICATION. A LOSS OF PRIME WAS INDUCED DURING TESTING AND THE PUMP EMITTED THE APPROPRIATE AUDIO-VISUAL ALERT. A CARTRIDGE WITH 100UNITS WAS CORRECTLY LOADED INTO THE PUMP. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE PUMP DELIVERED TOO MUCH INSULIN RESULTING IN PATIENT'S BLOOD GLUCOSE ( BG) LEVEL GOING LOW. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. THE LOW BG VALUE WAS UNKNOWN. THE PATIENT WAS TREATED WITH GLUCAGON SUBCUTANEOUS BY THE EMT AND WAS MONITORED IN THE EMERGENCY ROOM AND RELEASED WITH A BG OF 200MG/DL. THE REPORTER STATED THAT THE PATIENT IS NEW TO THE PUMP AND HAS BEEN ON ONLY FOR TWO WEEKS. TROUBLESHOOTING INDICATED THAT THE PRIME HISTORY SHOWED THAT THE PATIENT PRIMED 163.6 UNITS IN THE MORNING AND THE REPORTER CONFIRMED THAT THE PATIENT WAS DISCONNECTED AT THE TIME OF PRIMING. THE PATIENT AND THE MOTHER DENY SEEING LARGE PRIME VOLUME, SEEING ONLY A FEW DROPS COMING OUT DURING PRIME STEP. THE MOTHER STATED THAT THEY FILLED THE CARTRIDGE LAST NIGHT AND WOKE UP THIS MORNING WITH AN EMPTY CARTRIDGE. REVIEW OF THE PUMP HISTORY INDICATED NO LARGE PRIME VOLUME IN PRIME HISTORY, NO LARGE BOLUSES, THE MOM AND DAD DENIED LEAKING AT CARTRIDGE. THIS REPORT IS BEING MADE BECAUSE THE PATIENT EXPERIENCED A BG EXCURSION WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21585 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization