BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2070626 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02919
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE REPORT IS 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. (B)(6) 2009.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 07/06/2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. A REVIEW OF THE TOTAL DAILY DELIVERY HISTORY ACCURATELY REFLECTS THE USER PROGRAMMED RATES. 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 HEALTHCARE PROVIDER/REPORTER CLAIMED THAT THE PATIENT BECAUSE NON-RESPONSIVE AND HAD A BLOOD GLUCOSE OF "17 MG/DL". THE EMT TREATED THE PATIENT WITH DEXTROSE AND FOOD IN ROUTE TO THE HOSPITAL FOR OBSERVATION. THE REPORTER NOTED THAT THE PATIENT MANAGED HIS/HER DIABETES WITH THE ANIMAS PUMP. DURING TROUBLESHOOTING, THE REPORTER INDICATED THAT THE ANIMAS PUMP HAD 4-5 WARNINGS OF LOSS OF PRIME THE DAY PRIOR TO THE MEDICAL INTERVENTION. ANIMAS HEALTHCARE REPRESENTATIVE CONCLUDED THAT BESIDES THE LOSS OF PRIME ISSUE, THE ANIMAS PUMP WORKS ACCORDINGLY. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR HYPOGLYCEMIA WHILE USING THE ANIMAS INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP B201586

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| R