BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3033252 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03487
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE PATIENT REPORTEDLY PRIMED WHILE ATTACHED AT THE INFUSION SITE. THE PUMP USER GUIDE INSTRUCTS THE PATIENT TO DISCONNECT FROM THE SITE PRIOR TO PERFORMED THE REWIND, LOAD, OR PRIME STEPS. ADDITIONALLY, THE PUMP DISPLAYS A REMINDER MESSAGE INSTRUCTING THE PATIENT TO DISCONNECT FROM THE INFUSION SITE PRIOR TO PERFORMING THE PRIME STEP. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING AN INCIDENT IN WHICH THE PATIENT MAY HAVE INADVERTENTLY PRIMED 180.7 UNITS OF INSULIN WHILE ATTACHED AT THE SKIN SITE. THE PATIENT REPORTED THAT BLOOD GLUCOSE LEVELS DECREASED FROM 222 MG/DL TO 94 MG/DL OVER THE COURSE OF 3 HOURS. THE PATIENT REPORTED TAKING ORAL CARBOHYDRATE AND REPORTED THAT THE BLOOD GLUCOSE WENT AS LOW AS 86 MG/DL BUT DID NOT BELIEVE THAT THE BLOOD GLUCOSE WENT BELOW THAT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND WAS OBSERVED FOR SEVERAL HOURS AND THEN RELEASED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT SOUGHT MEDICAL INTERVENTION AFTER PRIMING WHILE ATTACHED TO THE INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136025 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization