BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2233090 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06444
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THERE ARE NO ALARMS RELATED TO THE COMPLAINT IN THE ALARM HISTORY. A REVIEW OF THE TOTAL DAILY DELIVERY AND THE BASAL DELIVERY HISTORY SHOWED THAT THE PUMP WAS DELIVERING ACCURATELY AND CORRECTLY REFLECTED THE USER'S ACTIVE BASAL PROGRAMMED RATE. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. A DAMAGED BATTERY COMPARTMENT WAS OBSERVED DURING VISUAL INSPECTION; THE BATTERY CAP IS ALSO STRIPPED AND WILL NOT PROPERLY HOLD POWER TO THE PUMP. THE USER GUIDE INSTRUCTS THE PATIENT TO REPLACE THE BATTERY CAP AT LEAST ONCE PER YEAR AND THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE EXPERIENCED A BLOOD GLUCOSE (BG) OF 600 MG/DL. THE PATIENT TREATED HERSELF WITH INSULIN INJECTIONS AND HER BG RESOLVED TO 130 MG/DL. THE PATIENT REPORTED THAT THE PUMP WAS EMITTING MULTIPLE LOSS OF PRIME WARNINGS FOR A FEW DAYS. SHE REPORTED THAT SHE CHANGED THE BATTERY THREE DAYS PRIOR AND WAS NOT SURE IF SHE DID A FULL REWIND, LOAD, AND PRIME AFTER THE BATTERY CHANGE. THE CARTRIDGE CAP WAS CONFIRMED TO BE SECURE AND THERE WAS NO CHANGE IN TEMPERATURE. THE PATIENT CONFIRMED THAT THE PUMP DID NOT REBOOT. THE PATIENT WAS ADVISED THAT THE PUMP REQUIRES A FULL REWIND, LOAD, AND PRIME AFTER A BATTERY CHANGE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    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 73 YR