BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2001717 · Received February 22, 2011

    Report

    Report Number
    2531779-2011-00972
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE PUMP DOWNLOAD CONFIRM THAT BASAL PROGRAM 1 WAS SET TO DELIVER 30.75 UNITS DAILY AND BASAL PROGRAM 2 WAS SET TO DELIVER 36.60 UNITS DAILY. THE BLACK BOX CONFIRMED THAT THE USER SWITCHED BETWEEN THE TWO BASAL PROGRAMS SEVERAL TIMES DURING THE PERIOD IN QUESTION. ON (B)(6) 2011, THERE WAS A CHANGE FROM BASAL PROGRAM 2 TO BASAL PROGRAM 1. THE FIRST REPORTED LOW BLOOD GLUCOSE EVENT ON (B)(6) 2011, THEREFORE OCCURRED WHILE THE PT WAS RUNNING THE HIGHER BASAL DELIVERY PROGRAM. ON (B)(6) 2011, THERE WAS A CHANGE FROM BASAL PROGRAM 2 BACK TO BASAL PROGRAM 1. THUS THE SECOND REPORTED LOW BLOOD GLUCOSE EVENT ON (B)(6) 2011 ALSO OCCURRED WHILE THE PT WAS RUNNING THE HIGH BASAL DELIVERY PROGRAM. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAM VALUES. THE PUMP WAS EXERCISED FOR 24 HRS WITH NO ISSUES.

    Description of Event or Problem · 1

    THE PT REPORTED HYPOGLYCEMIA ON (B)(6) 2011 AND (B)(6) 2011. SHE SAID THAT HER BLOOD GLUCOSE WAS 36MG/DL AND 40MG/DL RESPECTIVELY AND SHE TREATED HERSELF WITH ORAL CARBOHYDRATES BOTH TIMES. THE PT NOTED THAT HER BLOOD GLUCOSE RESOLVED TO TARGET WITHIN SEVERAL HRS. SHE REPORTED THAT THE BOLUS DELIVERY HISTORY IS CORRECT, SHE DID NOT PRIME THE PUMP WHILE ATTACHED, AND THE PUMP WAS NOT EXPOSED TO X-RAYS. THE PT STATED SHE DID NOT CHANGE FOOD OR ALCOHOL INTAKE AND SHE DID NOT INCREASE HER ACTIVITY LEVEL. SHE DENIED ACTIVATION OF DIFFERENT BASAL RATE PROGRAMS; SHE RUNS BASAL PROGRAM 1 AT ALL TIMES EXCEPT FOR SICK DAYS WHEN SHE ACTIVATES BASAL PROGRAM 2. BASAL PROGRAM 1 WAS SET TO DELIVER 30.75 UNITS DAILY AND BASAL PROGRAM 2 WAS SET TO DELIVER 36.60 UNITS DAILY. THE PT STATED SHE DID NOT SET ANY TEMPORARY BASAL RATES; SHE SUSPENDED THE PUMP SEVERAL TIMES TO REDUCE BASAL DELIVERY AND AVOID HYPOGLYCEMIA. SHE REVIEWED PUMP AND REPORTED THAT BASAL PROGRAM 1 WAS ACTIVE AT THE TIME OF THE CALL AND THE SETTINGS ARE CORRECT. THE PT NOTED THAT THE BASAL DELIVERY HISTORY SHOWS DELIVERY OF 33.53 UNITS ON (B)(6) 2011 AND 36.60 UNITS ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention