BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2223731 · Received August 25, 2011

    Report

    Report Number
    2531779-2011-06222
    Event Type
    Injury
    Date Received
    August 25, 2011
    Report Date
    July 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: NO DATA FROM THE TIME OF THE EVENT WAS AVAILABLE DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FOR THE AVAILABLE DATE RANGE 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 BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. UNRELATED TO THE COMPLAINT, THE PUMP CASING HAD SCRATCHES AND CHIPS MISSING; THIS ISSUE HAS NO EFFECT ON INSULIN DELIVERY FUNCTION.

    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. 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.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED SHE GOT LOW BLOOD GLUCOSE READING OF "50 MG/DL" AND "39 MG/DL" IN THE MORNING TIME ON (B)(6) 2011 AND (B)(6) 2011 RESPECTIVELY. THE PATIENT TOOK TREATMENT WITH CANDY AND OJ ON BOTH EVENTS. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE ASSESSED THE PATIENT'S ALLEGED OUT OF CONTROL BLOOD GLUCOSE BY EVALUATING THE ANIMAS PUMP. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THE ADVANCE FEATURES ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT'S USAGE. HOWEVER, THE BASAL RATE WAS FOUND TO BE INCORRECTLY SET. REPORTEDLY, THE BASAL RATE AT 12 AM TO 6:30 AM WAS SET TO 3.9 U PER HOUR AS OPPOSED THE RECOMMENDATION OF 0.950 U PER HOUR FROM 12 AM TO 6:30 AM. THE PATIENT REPORTEDLY WAS TAKING 19 UNITS OF INSULIN MORE THAN SHE SHOULD HAVE PER NIGHT BASED ON THE REPORTED BASAL SEGMENT. THE PATIENT WAS ADVISED TO CONSULT WITH HER HEALTHCARE PROVIDER TO ENSURE HER BASAL SETTINGS ARE CORRECT. THERE WAS NO EVIDENCE THAT THE ANIMAS PUMP MALFUNCTIONED. THIS COMPLAINT IS BEING REPORTED DUE TO USER ERROR AND BECAUSE THE PATIENT ALLEGEDLY BECAME HYPOGLYCEMIC TWICE WHILE THE PATIENT MANAGED HER DIABETES WITH THE ANIMAS PUMP. THE BASAL SETTING IN THE ANIMAS WAS INCORRECTLY PROGRAMMED AT THE TIME OF CONCERN.

    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 83 YR Life Threatening| R