BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2111682 · Received June 2, 2011

    Report

    Report Number
    2531779-2011-03874
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT THE PUMP EMITTED A LOSS OF PRIME WARNING ON (B)(6) 2011 AT 4:28 PM. THE AMOUNT OF INSULIN REMAINING AT THIS TIME WAS 109 UNITS. THE PUMP HISTORY INDICATED THAT THE PUMP WAS PRIMED AT 4:32 PM AND LOST PRIME AGAIN AT 4:37PM. THE PUMP CONTINUED TO EMIT LOSS OF PRIME WARNINGS UNTIL 4:40 PM WHEN A PRIME WAS ATTEMPTED, HOWEVER WAS UNSUCCESSFUL. A REWIND, AND ALIGN WERE THEN COMPLETED AT 4:40PM. A REWIND WAS COMPLETED AGAIN AT 4:42 PM. NO ACTION WAS TAKEN AND A "NO PRIME" WARNING WAS EMITTED AT 4:46PM. AT 5:35 PM AN ALIGN WAS ATTEMPTED AND A "NO CARTRIDGE DETECTED" WARNING WAS GIVEN. A REWIND AND ALIGN WERE ATTEMPTED AGAIN WITH THE SAME RESULT. THE PATIENT'S WIFE INDICATED THAT THE PATIENT WAS NOT CONNECTED TO THE PUMP WHILE ATTEMPTING TO REWIND, ALIGN OR PRIME THE PUMP, AND NO BASAL OR BOLUS INSULIN DELIVERY OCCURRED AFTER 4:25 PM, THEREFORE THERE IS NO INDICATION THAT THE PUMP DELIVERED ANY INSULIN TO THE PATIENT DURING THIS TIME PERIOD. THE PUMP WAS EVALUATED AND FOUND TO BE DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. 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. THE USER GUIDE INSTRUCTS USERS TO DISCONNECT FROM THE INFUSION SET PRIOR TO INITIATING THE PRIME / REWIND SEQUENCE. ADDITIONALLY, THE PUMP NOTIFIES THE USER TO DISCONNECT FROM THE INFUSION SET PRIOR TO INITIATING THE REWIND OF THE MOTOR. THE USER MUST MANUALLY CONFIRM THIS ALERT BEFORE PROCEEDING WITH THE REWIND PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO HYPOGLYCEMIA (1.2MMOL/L). THE PATIENT'S WIFE BELIEVES THAT IT IS DUE TO OVER DELIVERY OF INSULIN BY THE PUMP, BUT DOES NOT KNOW THE REASON. THE PUMP REPORTEDLY INDICATED "PUMP NOT PRIMED, NO DELIVERY". THE PATIENT DISCONNECTED, RE-PRIMED AND RECONNECTED TO THE PUMP. THE CARTRIDGE REPORTEDLY CONTAINED 109 UNITS AT THIS TIME. APPROXIMATELY 30 MINUTES LATER THE PATIENT'S WIFE WAS REPORTEDLY ATTEMPTING TO CHANGE OUT THE CARTRIDGE, AND NOTICED THE CARTRIDGE WAS EMPTY. THE PATIENT'S WIFE REPORTS ATTEMPTING TO REWIND, ALIGN AND PRIME A NEW CARTRIDGE, HOWEVER REPORTS THAT THE PUMP CONTINUED TO PRIME UNTIL EMPTY. THIS REPORTEDLY OCCURRED 2 TIMES. THE PATIENT'S WIFE THEN CALLED AN AMBULANCE TO TRANSPORT THE PATIENT TO THE EMERGENCY ROOM. THE PATIENT'S BLOOD GLUCOSE WAS 4.4 MMOL/L UPON ARRIVAL AND WHEN DOWN TO 1.6 MMOL/L AND THEN 1.2 MMOL/L. THE PUMP HISTORY WAS REVIEWED WITH THE PATIENT, AND THE PRIME HISTORIES INDICATE THAT THE PUMP WAS PRIMED 10.3 AND 3.2 UNITS. THIS IS BEING REPORTED DUE TO THE PATIENT HOSPITALIZATION AND HYPOGLYCEMIA. THIS IS ALSO BEING REPORTED DUE TO THE PUMP DISPENSING INSULIN DURING THE REWIND/PRIME PHASE. THE PATIENT WAS REPORTEDLY DISCONNECTED FROM THE PUMP AT THIS TIME, THEREFORE THERE IS NO INDICATION IF THESE EVENTS ARE RELATED.

    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 Hospitalization| L