BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1915068 · Received November 30, 2010

    Report

    Report Number
    2531779-2010-02609
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 30, 2010
    Report Date
    October 30, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. THE PT REPORTED THAT HE INADVERTENTLY ADMINISTERED EXCESS INSULIN BY PRIMING THE PUMP WHILE ATTACHED TO THE INFUSION SET. THE PUMP USER GUIDE INSTRUCTS THAT THE FIRST STEP OF A CARTRIDGE CHANGE IS TO DISCONNECT THE INFUSION SET FROM THE BODY. IT ALSO ADVISES THE USER NOT TO CONNECT THE INFUSION SET TO THE BODY UNTIL AFTER THE PRIME PROCESS HAS BEEN COMPLETED. THE PUMP USER GUIDE INSTRUCTS USERS TO DISCONNECT FROM THE INFUSION SET PRIOR TO PRIMING IT. ADDITIONALLY, THE PUMP NOTIFIES THE USER TO DISCONNECT FROM THE INFUSION SET THREE TIMES DURING THE PRIME / REWIND SEQUENCE.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 10/02/2012 DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED NO ACTIVITY OUTSIDE NORMAL USE. THERE WAS NO DATA FROM THE TIME OF THE INADVERTENT INFUSION DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. ON TESTING, THE PUMP DISPLAYED THE APPROPRIATE WARNING BEFORE PRIMING. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    THE PT WAS HOSPITALIZED TO MONITOR BLOOD GLUCOSE LEVELS AFTER HE PRIMED THE PUMP WHILE ATTACHED TO THE INFUSION SET. HE SAID THAT HE WAS DOING A ROUTINE CHANGE OF INFUSION SET AND CARTRIDGE; HE HAD COMPLETED THE REWIND, LOAD CARTRIDGE, AND PRIME STEPS W/O ISSUE. HE THEN INSERTED THE INFUSION SET AND NOTED THAT THE DISPLAY SCREEN HAD TIME OUT. THE PT REPORTED THAT HE ATTACHED THE TUBING TO THE INFUSION SET AND RETURNED TO THE EZPRIME SCREEN. AT THAT POINT, HE AGAIN COMPLETED THE REWIND, LOAD CARTRIDGE, AND PRIME STEPS, BUT THIS TIME HE WAS CONNECTED TO THE INFUSION SET. HE SAID, HE REC'D A MESSAGE THAT SAID THAT THERE WAS NO CARTRIDGE DETECTED. HE REMOVED THE CARTRIDGE AND STATED THAT THE CARTRIDGE WAS EMPTY. THE PT STATED THAT HE HAD ABOUT 126 UNITS OF INSULIN IN THE CARTRIDGE; THE PRIME HISTORY SHOWED TWO PRIMES OF 0.6 UNITS AND 126.8 UNITS. HE DENIED ANY PUDDLES OF INSULIN OR WETNESS AROUND THE INFUSION SITE OR ON HIS CLOTHES. THE PT NOTED THAT HIS BLOOD GLUCOSE WAS 57 MG/DL AT THE TIME OF THE EVENT; HE DENIED SIGNS OR SYMPTOMS OF HYPOGLYCEMIA. HE DISCONNECTED FROM THE PUMP, CONSUMED QUICK ACTING CARBOHYDRATES, AND WAS TRANSPORTED TO THE EMERGENCY ROOM. THE PT REPORTED THAT HIS BLOOD GLUCOSE WAS 353MG/DL ON ADMISSION TO THE HOSPITAL AND CONTINUED TO ELEVATE TO >500MG/DL. HE STATED THAT HE DID NOT RECEIVE TREATMENT; HE RESUMED PUMP THERAPY ABOUT 3 HRS LATER AND LEFT THE HOSPITAL ABOUT FOUR HRS AFTER ADMISSION. THE PT NOTED THAT HIS BLOOD GLUCOSE WAS 453MG/DL WHEN HE ARRIVED HOME AND HE STATED THAT HE FELT FINE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization