BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2213239 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05940
    Event Type
    Injury
    Date Received
    August 16, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY FOR (B)(6) 2011 SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN THE BLACK BOX OR ALARM HISTORY. THE PUMP PRIME HISTORY SHOWED THAT THE PATIENT BEGAN USING THE PUMP ON (B)(6) 2011 AT 16:07 WITH A PRIME OF 3.27 UNITS. THE PUMP DELIVERED A PROGRAMMED BASAL RATE UNTIL (B)(6) 2011 AT 21:39 WHEN THE PATIENT PERFORMED A REWIND, LOAD, AND PRIME SEQUENCE; THE RECORDED PRIME VOLUME WAS 5.36 UNITS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY DEFECTS WERE FOUND DURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    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 PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2011 TO REPORT A LOW BLOOD GLUCOSE (BG) WHILE ON NEW PUMP. AT AN UNSPECIFIED TIME ON (B)(6) 2011 THE PATIENT REPORTED A LOW BG OF 37MG/DL WITH SYMPTOMS OF FEELING SWEATY AND CONFUSED. IN RESPONSE TO THE LOW, IT WAS REPORTED THAT THE PATIENT CONTACTED EMERGENCY MEDICAL SERVICES (EMS) AND ATE 4 GLUCOSE TABLETS AND A PEANUT BUTTER GRAHAM CRACKER. WHEN SHE RETESTED HER BG IT WAS 58MG/DL AND TOOK 2 ADDITIONAL GLUCOSE TABLETS. WHEN EMS ARRIVED, THE PATIENT CLAIMED HER BG WAS UP TO 88MG/DL AND SHE REFUSED TRANSPORT TO THE HOSPITAL. HOWEVER, SOMETIME AFTERWARDS HER BG DROPPED AGAIN TO 53MG/DL AND EMS WAS CALLED AGAIN. THE PATIENT WAS INSTRUCTED TO DRINK 8OZ OF MILK AND TAKE 4 GLUCOSE TABLETS BEFORE EMS ARRIVAL. WHEN EMS ARRIVED, THE PATIENT REPORTED HER BG WAS 35MG/DL WHEN TESTED BY EMERGENCY SERVICE PERSONNEL. THE PATIENT WAS ADMINISTERED ORAL GLUCOSE GEL AND TRANSPORTED TO THE HOSPITAL. THE PATIENT REPORTED THAT HER GLUCOSE CONTINUED TO RISE AND FALL WHILE IN THE HOSPITAL AND STATED SHE WAS TREATED WITH DEXTROSE SOLUTION AND RELEASED FROM THE EMERGENCY ROOM AT 11PM THAT EVENING WITH A BG OF 290 MG/DL AND CONNECTED BACK TO OLD PUMP. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CLAIMED PRIOR TO THE LOW BG, SHE HAD SWITCHED THE INSULIN CARTRIDGE FROM HER OLD PUMP TO HER NEW PUMP. PRIOR TO SWITCHING CARTRIDGE FROM OLD PUMP TO NEW PUMP, THE PATIENT INFORMED CUSTOMER SUPPORT THAT SHE CHANGED THE CARTRIDGE THAT MORNING AND WAS FULL (200 UNITS). AT THE TIME THE INCIDENT (LOW BG) OCCURRED, THE PATIENT CLAIMED THE CARTRIDGE HAD 113 UNITS OF INSULIN. THE PATIENT INFORMED CUSTOMER SUPPORT THAT 18-23 UNITS OF THE INSULIN WAS ACCOUNTED FOR (INCLUDES PRIMING OF OLD AND NEW PUMP, BOLUS DELIVERY AND BASAL) AND CLAIMED SHE WAS DISCONNECTED FROM PUMP DURING CARTRIDGE CHANGE TO NEW PUMP. DURING REVIEW OF SUBJECT PUMP, A PRIME OF 3.2U AT 4:07PM WAS NOTED AND A TOTAL DAILY DELIVERY SHOWED ONLY 4.3U FROM BASAL DELIVERY. CUSTOMER SUPPORT WAS UNABLE TO DETERMINE CAUSE OF LOW BG AFTER CHANGE TO THE NEW PUMP.

    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 80 YR