BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2842597 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13840
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/03/2015 WITH THE FOLLOWING FINDINGS: PUMP IS UNABLE TO HOLD PRIME UPON FIRST ATTEMPT; LOSS OF PRIME WAS DUPLICATED. THE BLACK BOX SHOWS LOSS OF PRIME WARNING ASSOCIATED WITH A LOW NON-ZERO FORCE. ON (B)(6) 2012 10:21 LOSS OF PRIME WITH A LOW NON-ZERO FORCE; DELIVERIES RESUMED AT 17:54. PUMP BOOTS TO THE VERIFY SCREEN WITH NO ERRORS. A REWIND, LOAD STEP WERE COMPLETED. UNABLE TO COMPLETE ALL STEPS DUE TO RECURRING LOSS OF PRIME. THE FORCE SENSOR CALIBRATION CHECK IS OUT OF SPECIFICATION. REMOVED PUMP COVER; THE SENSOR RESISTANCE WAS FOUND TO BE OUT OF SPECIFICATION. CONTAMINATION WAS FOUND ON THE FORCE SENSOR HOUSING. BATTERY COMPARTMENT IS CRACKED ON THE SIDE AT THE THREADS AND CRACKED BELOW NEAR THE COVER. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S FATHER CONTACTED ANIMAS TO REPORT MULTIPLE LOSS OF PRIME WARNINGS. THE REPORTER STATED THAT THE LOSS OF PRIME WARNINGS STARTED FREQUENTLY THE PAST MONTH AND CLAIMED THE PUMP WOULD LOSE PRIME AS MANY AS 3X PER DAY. THE PATIENT¿S FATHER STATED THE MOST RECENT WARNING OCCURRED THIS MORNING WHEN THE PATIENT WOKE UP TO THE ALARM. IT IS NOT KNOWN HOW MUCH TIME ELAPSED BETWEEN WHEN THE PUMP PROVIDED WARNING AND PATIENT WOKE AND ACKNOWLEDGED IT. THE PATIENT'S BLOOD GLUCOSE (BG) AT THE TIME WAS 441 MG/DL AND THE REPORTER STATED THE PATIENT TESTED POSITIVE FOR HIGH KETONES AND WAS EXPERIENCING MILD FATIGUE. CUSTOMER SUPPORT ADVISED THE REPORTER THAT THE PATIENT FOLLOW HIS HCP'S RECOMMENDATION TO TREAT A HIGH BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, CUSTOMER SUPPORT NOTED THAT THE PATIENT WAS ABLE TO PRIME AND DELIVER AN AIR BOLUS, BUT THE PATIENT'S FATHER STATED THAT THE LOSS OF PRIME WAS SPORADIC AND WAS OCCURRING SEVERAL HOURS AFTER THEY HAD REPRIMED THE PUMP. THE REPORTER CONFIRMED THE CARTRIDGE CAP WAS SECURED AND THERE WAS NO TRAUMA TO THE PUMP OR ANY EXTREME TEMPERATURE CHANGES. THE PATIENT'S FATHER REPORTED THAT THE PATIENT HAS CHANGED OUT THE CARTRIDGE AND USED CARTRIDGES FROM A DIFFERENT BOX; HOWEVER, CONTINUES TO RECEIVE FREQUENT AND MULTIPLE LOSS OF PRIME WARNINGS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER RECEIVING A LOSS OF PRIME WARNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening