BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3813288 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13722
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURNED AT THIS TIME. IF THE DEVICE IS RETURNED TO ANIMAS, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA DID NOT FIND ANY RELATED WARNINGS OR ALERTS. THE TOTAL DAILY DELIVERY APPEARED TO BE INCONSISTENT DUE TO A TIME/DATE ISSUE. ON INVESTIGATION, THE PUMP POWERED UP AND FUNCTIONED PROPERLY. ALL THE BUTTONS RESPONDED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENCES. THE PUMP DELIVERY ACCURACY WAS WITHIN REQUIRED SPECIFICATIONS. THE BOLUS DELIVERY EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. THE REPORTED INADVERTENT INFUSION ISSUE WAS ATTRIBUTED TO A USE ERROR AND NO DEFECT WAS FOUND WITH THE PUMP DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT CONTACTED ANIMAS, ALLEGING A HYPOGLYCEMIC EVENT RESULTING FROM AN INADVERTENT INFUSION. REPORTEDLY, DUE TO A RECURRING LOSS OF PRIME ISSUE THE PATIENT¿S BLOOD GLUCOSE (BG) READING WAS ELEVATED AND SINCE ALTERNATE TREATMENT METHOD WAS NOT AVAILABLE AT THE TIME, THE PATIENT HAD REMOVED THE CARTRIDGE FROM THE PUMP AND USED IT TO SELF-ADMINISTER AN UNKNOWN AMOUNT OF INSULIN WHILE ATTACHED. THE PATIENT REPORTED THAT WITHIN AN HOUR HIS BG READING WAS AT 82 MG/DL WITH NO ASSOCIATED SYMPTOMS AND HE WAS SUBSEQUENTLY ADMITTED TO THE EMERGENCY ROOM (ER). AT THE TIME OF THE CALL, THE PATIENT REMAINED IN THE ER AND HIS BG CONTINUED TO BE MONITORED. THE PATIENT¿S LAST BG READING WAS REPORTED TO BE AT 64 MG/DL. THE PATIENT REPORTEDLY WAS GIVEN ALTERNATE DELIVERY METHOD AND WAS NO LONGER ON PUMP THERAPY. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A SERIOUS HYPOGLYCEMIA EVENT REQUIRING HOSPITALIZATION. THE LOW BG EXCURSION WAS ATTRIBUTED TO A USE ERROR IN THAT THE PATIENT HAD MANUALLY INFUSED AN UNKNOWN AMOUNT OF INSULIN WHILE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289293 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L