BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2102666 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03684
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) 2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2011 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. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED ON (B)(6) 2011 THAT HE HAS BEEN EXPERIENCING BLOOD GLUCOSE (BG) EXCURSIONS SINCE STARTING ON A REPLACEMENT PUMP EARLIER IN (B)(6). HE STATED THAT HE WILL GIVE A BOLUS FOR CARBOHYDRATES, AND HIS BG WILL BE BETWEEN 200 MG/DL AND 300 MG/DL. HE SAID THAT HE WILL THEN GIVE A CORRECTION BOLUS, AND HIS BG WILL DROP TO AROUND 30 MG/DL. THE PATIENT DID NOT REPORT ANY SYMPTOMS. THE PATIENT SAID THAT HE TREATED THE LOW BGS WITH CARBOHYDRATES, AND THAT NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT REPORTED THAT HE PROGRAMMED THE REPLACEMENT PUMP BY HIMSELF WHEN HE RECEIVED IT. A REVIEW OF THE PUMP WITH ANIMAS CUSTOMER SUPPORT (CS) INDICATED THAT THE SETTINGS WERE INCORRECT. CS ASSISTED THE PATIENT IN CORRECTING THE SETTINGS, AND THE PATIENT HAS CONTINUED USING THE PUMP WITHOUT FURTHER REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention