BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2900370 · Received January 7, 2013

    Report

    Report Number
    2531779-2013-00315
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 04/19/2013 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 REVEALED MULTIPLE "PUMP NOT PRIMED" WARNINGS. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE WITHIN SPECIFICATION. THE REWIND, PRIME AND LOAD STEPS WERE SUCCESSFULLY PERFORMED WITH NO ALARMS NOTED. THE FORCE SENSOR WAS FOUND TO BE WITHIN CALIBRATION. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. A LOSS OF PRIME WAS INDUCED DURING TESTING AND THE PUMP GAVE THE APPROPRIATE VISUAL AND AUDIBLE ALERT. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE FORCE SENSOR CIRCUIT. NO LOSS OF PRIMES OCCURRED DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6)2012, MOM REPORTS PUMP LOST PRIME AGAIN TODAY AT SCHOOL ABOUT LUNCH TIME AND AS MOM WAS DRIVING TO THE SCHOOL, THE SCHOOL NURSE ATTEMPTED TO REPRIME THE PUMP AND INADVERTENTLY PRIMED 64 UNITS INTO THE PATIENT . MOM DID NOT KNOW THE NURSE HAD PRIMED INSULIN INTO THE PATIENT AND TOOK THE PATIENT HOME: AT HOME, THE BLOOD GLUCOSE (BG) READING BG WAS 58 MG/DL AND THE PATIENT WAS GIVEN JUICE. FIFTEEN MINUTES LATER, AS BG WAS STILL 58 MG/DL , MOM CALLED 911 AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL, INCOHERENT, WITH BG OF 47 MG/DL AND NOT COHERENT. THE PATIENT WAS ADMITTED AND GIVEN INTRAVENOUS FLUIDS AND IS STILL HOSPITALIZED. PUMP HISTORY SHOWED 9 PRIMES TOTALLING 64 UNITS. THERE WAS ONE LOSS OF PRIME WARNING TODAY. MOM IS INSISTING THE PUMP BE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT INADVERTENT INSULIN INFUSION RESULTED IN HOSPITALIZATION FOR HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6343 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization