BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2894224 · Received January 3, 2013

    Report

    Report Number
    2531779-2013-00091
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 9, 2012
    Report Date
    December 9, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE BECAME SHAKY AND BLACKED OUT WHILE TRAVELING WITH A FRIEND. THE PATIENT WAS UNSURE HOW LOW HER BLOOD GLUCOSE (BG) HAD BEEN, BUT NOTED THAT AFTER TREATING THE LOW BG, HER BG TESTED AS 56MG/DL AND AT THE TIME OF THE CALL WITH ANIMAS CUSTOMER TECHNICAL SUPPORT (CTS) HER BG WAS 72MG/DL. THE PATIENT STATED THAT SHE HAD A DRINK "LOADED WITH CARBS" AND ATE SOME FOOD TO TREAT THE LOW BG. DURING TROUBLESHOOTING, THE PATIENT FOUND THAT SHE HAD ACCIDENTALLY BOLUSED TWICE AND FOUND THAT THE INSULIN ON BOARD (IOB) FEATURE HAD BEEN TURNED OFF. THE PATIENT STATED THAT SHE DID NOT REMEMBER GIVING THE SECOND BOLUS. THE PATIENT TURNED THE IOB SETTING ON AND AGREED TO CONTACT HER HEALTHCARE PROVIDER TO FIND OUT WHAT THE APPROPRIATE IOB DURATION SHOULD BE. CTS ADVISED THE PATIENT TO MONITOR BGS CLOSELY AND TO GO TO THE ER IF SHE COULD NOT KEEP HER BG UP. THERE IS CURRENTLY NO INDICATION OR ALLEGATION OF A PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED SEVERE HYPOGLYCEMIA RELATED TO MISTAKENLY OVER-BOLUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening