BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2922214 · Received January 18, 2013

    Report

    Report Number
    2531779-2013-00844
    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
    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 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

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A CARTRIDGE CHANGE WAS NOTED IN PUMP HISTORY ON (B)(4) 2012; THE PUMP WAS PRIMED WITH NO BASAL DELIVERY ISSUES NOTED. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE WITHIN SPECIFICATION. THE PUMP POWERED UP TO THE "VERIFY" SCREEN AND WAS SUCCESSFULLY PRIMED AND ACCURATELY RECORDED IN PUMP HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO ALARM OCCURRED DURING TESTING. THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION. THE REPORTED ISSUE WAS NOT DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    Description of Event or Problem · 1

    THE REPORTER AND THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A BLOOD GLUCOSE (BG) OF 42MG/DL WITH LETHARGY ON (B)(6) 2012. SHE WAS TREATED WITH A 10% DEXTROSE DRIP AND HER BG WENT UP TO 70MG/DL. THE PATIENT'S BG REMAINED IN THE RANGE WHILE ON DEXTROSE DRIP. THE HISTORY CONFIRMED THAT THERE WAS AN EMPTY CARTRIDGE ALARM AT 1:19AM AND THE PATIENT REPORTED THAT SHE CHANGE THE CARTRIDGE AND ENTIRE SET-UP. THE PATIENT CONFIRMED THAT SHE DID THE REWIND, LOAD AND PRIME STEPS WHILE DISCONNECTED AND WITHOUT ISSUE. THE PATIENT REPORTED THAT 30-60 MINUTES LATER THE CGM BEGAN TO ALARM LOW AND SAID BG WAS IN THE 90'S. SHE CONTINUED TO TREND DOWNWARDS TO 70MG/DL. SHE TREATED WITH JUICE AND QUICK STICKS. SHE REMOVED THE CARTRIDGE AND THE CARTRIDGE SHE HAD JUST FILLED HAD ONLY SEVEN UNITS REMAINING. HER BG CONTINUED TO TREND DOWN AND SHE WAS THEN TAKEN TO THE HOSPITAL. TROUBLESHOOTING WITH CUSTOMER SUPPORT INDICATED THAT SHE CONFIRMED THE ORIGINAL PRIME DONE OF 13.8 UNITS. THE HISTORY SHOWED THREE ADDITIONAL PRIMES THAT SHE REPORTEDLY DID NOT DO. THERE WAS NO BUT TON OR KEYPAD ISSUE. THE PATIENT STATED THAT SHE WEARS THE PUMP IN A TIGHT PLACE TO PREVENT ACCIDENTAL BUTTON PRESSES BUT SHE DOES HAVE A LONG TUBING AND WHEN SHE PLACES THE PUMP ON BEDSIDE IT DOES NOT LOCK. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S HYPOGLYCEMIC EVENT WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27928 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization