BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3151511 · Received June 7, 2013

    Report

    Report Number
    2531779-2013-07882
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED TO ANIMAS FOR AN UNRELATED ISSUE AND HAS BEEN INVESTIGATED WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS REFLECTED THE USER¿S PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY SCREEN WAS NOTED TO BE DISCOLORED. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY WITHOUT DISCOLORATION. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 TO REPORT THAT HE WAS CURRENTLY IN THE HOSPITAL DUE TO RENAL FAILURE UNRELATED TO AN ISSUE WITH THE INSULIN PUMP. THE PATIENT REPORTED THAT WHILE HOSPITALIZED FOR THE RENAL FAILURE, HE HAD BEEN ORDERED TO TAKE NOTHING BY MOUTH; HOWEVER REMAINED ON INSULIN PUMP THERAPY DURING THAT TIME, RECEIVING HIS NORMAL BASAL RATE OF 0.6 UNITS OF INSULIN PER HOUR. THE PATIENT REPORTED THAT AS A RESULT OF CONTINUED INSULIN ADMINISTRATION WITHOUT FOOD INTAKE, ON (B)(6) 2013, HIS BLOOD GLUCOSE AT NIGHT DROPPED TO 1 MMOL/L AND HE BECAME UNCONSCIOUS. THE PATIENT WAS REPORTEDLY TREATED WITH GLUCAGON AND DEXTROSE AND WAS ASSISTED BY THE HOSPITAL STAFF. THE PATIENT¿S BG REPORTEDLY RESPONDED BY ELEVATING TO 7 MMOL/L. THE INSULIN PUMP WAS REPORTEDLY REMOVED FROM THE PATIENT UNTIL THE BASAL RATE COULD BE REDUCED. THERE WAS NO ALLEGATION OF A PUMP MALFUNCTION. THE PUMP WAS NOT REQUESTED BACK FOR INVESTIGATION AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT FAILED TO DISCONTINUE/ADJUST INSULIN PUMP THERAPY DURING A TIME OF MEDICALLY-ORDERED FASTING DURING A HOSPITALIZATION UNRELATED TO DIABETES AND AS A RESULT, EXPERIENCED A HYPOGLYCEMIC EVENT WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253372 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| R