BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2800597 · Received October 22, 2012

    Report

    Report Number
    2531779-2012-12612
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    September 23, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    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. .

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/05/2015 WITH THE FOLLOWING FINDINGS: 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. REVIEW OF THE BLACK BOX DATA FOUND THAT DATE RANGE DID NOT COVER THE COMPLAINT DATE DUE TO CONTINUED CUSTOMER USE. REVIEW OF AVAILABLE DATE RANGE FOUND THAT THE TOTAL DAILY DELIVERY ADDED UP CORRECTLY AND REFLECTED THE USER¿S PROGRAMMED BASAL RATE. THE INSULIN ON BOARD (IOB) DURATION WAS SET AT 4 HOURS. THE CAPS WERE NOT RETURNED AND TEST CAPS WERE USED IN THE EVALUATION. THE PUMP POWERED UP TO THE DISPLAY WITH AUDITORY AND VIBRATORY FEATURES. A LOAD STEP MALFUNCTION WAS ENCOUNTERED DURING THE REWIND/LOAD/PRIME SEQUENCE DUE TO FORCE SENSOR FAILURE AND THE REMAINING TESTING FOR THE IOB ISSUE WAS UNABLE TO BE PERFORMED. THE ALLEGED IOB CALCULATION ISSUE WAS UNABLE TO BE FULLY INVESTIGATED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED ANIMAS (ANM) AND REPORTED A LOW BLOOD GLUCOSE (BG) EVENT. THE PATIENT INDICATED THAT FOR THE PAST FEW WEEKS, SHE HAD BEEN GETTING REALLY BAD LOW BG LEVELS IN THE "32-44 MG/DL" RANGE. SHE ALSO MENTIONED THAT 45 MINUTES AFTER BOLUSING FOR A MEAL, THE IOB WOULD SHOW 0.00 UNITS. THE PATIENT WAS UNWILLING TO PROVIDE DETAILS ON HOW SHE CORRECTED FOR THE LOW BG EPISODES. THE PATIENT DENIED, HOWEVER, THAT SHE HAD TO GO TO A HOSPITAL DURING THE TIME OF CONCERN. SHE ALSO DID NOT REPORT ANY SYMPTOMS. THROUGH TROUBLESHOOTING, IT WAS DETERMINED THAT THE PUMP'S IOB SETTING WAS NOT TURNED ON. THE ANM REPRESENTATIVE INVOLVED IN THIS CONTACT WALKED THE PATIENT THROUGH ENABLING THE IOB SETTING IN THE SUBJECT PUMP. IT IS UNCLEAR IF THE PATIENT THOUGHT THAT THE IOB FEATURE WAS TURNED ON DURING THE TIME OF CONCERN. ACCORDING TO THE OWNER'S MANUAL, THE PUMP'S IOB FEATURE HELPS TO PREVENT "STACKING" INSULIN AND CAN HELP TO REDUCE THE RISK OF HYPOGLYCEMIA. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING/TRAINING. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT REPORTEDLY DEVELOPED LOW BG LEVELS SUGGESTIVE OF SEVERE HYPOGLYCEMIA. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE PUMP AND/OR USE-ERROR CONTRIBUTED TO THE PATIENT'S INJURIES.

    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 49 YR Life Threatening