BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2318227 · Received November 1, 2011

    Report

    Report Number
    2531779-2011-08136
    Event Type
    Injury
    Date Received
    November 1, 2011
    Report Date
    October 5, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 2011 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2001 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON APPROPRIATELY TO THE VERIFICATION SCREEN WITH FUNCTIONAL AUDITORY ALARMS. EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, CORROSION INSIDE THE BATTERY COMPARTMENT, AND A BATTERY COMPARTMENT LEAK. DURING TESTING, THE PUMP DID NOT DETECT A FILLED CARTRIDGE DURING THE LOAD STEP; TESTING COULD NOT BE ADEQUATELY COMPLETED BECAUSE THE PUMP COULD NOT DETECT THE CARTRIDGE. INVESTIGATION REVEALED THE FORCE SENSOR IS OUT OF CALIBRATION. THERE WAS EVIDENCE OF MOISTURE DAMAGE NOTED ON THE FORCE SENSOR. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER/DOCTOR CONTACTED ANIMAS ON BEHALF OF THE PATIENT AND REPORTED THAT THE PATIENT DEVELOPED A LOW BLOOD GLUCOSE (BG) LEVEL OF "31 MG/DL" AND RECEIVED GLUCAGON TREATMENT. THE PATIENT ADMITTED THAT SHE HAD GOTTEN A LOSS OF PRIME ALARM AND PRIMED WHILE ATTACHED. THE PUMP WAS REPLACED DUE TO A DISPLAY ISSUE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER INDICATED THAT THE PATIENT SUFFERED A BG LEVEL LESS THAN "40 MG/DL" AND RECEIVED MEDICAL TREATMENT. HOWEVER, THE PATIENT'S INJURY CAN BE ATTRIBUTED TO USE ERROR SINCE THE PATIENT INADVERTENTLY SELF-ADMINISTERED INSULIN.

    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 46 YR Life Threatening| R