BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2241921 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06697
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT HER BLOOD GLUCOSE ELEVATED TO ABOVE 546 MG/DL WHILE SHE MANAGED HER DIABETES WITH THE ANIMAS PUMP. ON (B)(6) 2011, THE PATIENT AWOKE WITH A BLOOD GLUCOSE READING OF "155 MG/DL." SUBSEQUENTLY, HER BLOOD GLUCOSE BEGAN TO RISE RAPIDLY TO ABOVE 600 MG/DL. AFTER THE PATIENT REPORTEDLY CHANGED THE INFUSION SITE, HER BLOOD GLUCOSE DECREASED TO 300 MG/DL BUT THEN ROSE TO 600 MG/DL AGAIN. THE PATIENT WAS CONCERNED ABOUT WHETHER THE ANIMAS PUMP WAS WORKING PROPERLY. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE ASSESSED THE PATIENT'S ALLEGED ELEVATED BLOOD GLUCOSE BY EVALUATING THE ANIMAS PUMP. THE ADVANCE FEATURES AND THE BASAL SEGMENT ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT'S USAGE. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THERE WERE NO ISSUES SUCH AS LEAKAGE AND AIR BUBBLES WITH THE INFUSION SET OR THE INSULIN CARTRIDGE. THERE IS NO SIGN OF INFUSION SITE ISSUES SUCH AS REDNESS, SWELLING, HARDNESS OR BLEEDING. THERE WAS NO SIGN OF A KINK OR BENDING OF THE CANNULA AT THE INFUSION SITE. THE PATIENT REPORTEDLY WAS ABLE TO PRIME SUCCESSFULLY WITH ANIMAS PUMP. IT WAS NOTED THAT THE KEYPAD WAS INTERMITTENTLY WORKING BUT THERE WAS NO EVIDENCE THE PATIENT'S INSULIN TREATMENT VIA THE PUMP WAS HINDERED DUE TO THE KEYPAD ISSUE. THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO MECHANICAL DELIVERY PROBLEM ASSOCIATED WITH THE ALLEGED EVENT. IT IS NOT CLEAR WHAT CONTRIBUTED TO THE PATIENT'S ELEVATED BLOOD GLUCOSE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY HAD BLOOD GLUCOSE OF OVER 600 MG/DL WHILE SHE MANAGED HER DIABETES WITH THE ANIMAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R