BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMIGO INSULIN PUMP

    MDR report key: 2624070 · Received April 17, 2009

    Report

    Report Number
    1066380-2009-00001
    Event Type
    Other
    Date Received
    April 17, 2009
    Date of Event
    March 14, 2009
    Report Date
    April 16, 2009
    Manufacturer
    NIPRO DIABETES SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K071613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY AND CONCLUSIONS: THE DELIVERY ACCURACY OF THE PUMP PASSED AND THEREFORE IS WITHIN THE ACCEPTABLE + OR - 5% TOLERANCE. THUS, THE PUMP WAS FUNCTIONING AS DESIGNED AND WAS NOT THE ROOT CAUSE OF THE HIGH BLOOD SUGAR. TWO DAYS PRIOR TO THE COMPLAINT ON (B)(6) 2009, THE PT DID NOT DELIVER ANY BOLUSES FOR FOOD INTAKE WHICH MAY RESULT IN THE HIGH BLOOD SUGAR EXPERIENCED BY THE PT. THE BACK LABEL OF THE PUMP APPEARS TO HAVE BEEN INTENTIONALLY REMOVED BY THE PT FOR AN UNK REASON. THE PUMP IS FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    PT CALLED CLINICIAN CELL PHONE ON SATURDAY (B)(6)-2009 AT 1:18PM. SHE CALLED TO REPORT THAT HER BLOOD SUGARS HAVE BEEN VERY HIGH FOR SEVERAL DAYS. SHE STATES IT IS ALSO REPORTED HIGH KETONES IN THE URINE. SHE SAID SHE HAS BEEN TRYING TO LOWER HER BLOOD SUGARS BY TAKING CORRECTION BOLUSES AND IT DID NOT HELP. SHE CALLED ANOTHER CLINICIAN EARLIER WHO INSTRUCTED HER TO DISCONNECT FROM THE PUMP AND TAKE A CORRECTION BY SUBCUTANEOUS INJECTION AND CALL ME IN A COUPLE OF HOURS. THE PT FOLLOWED HER INSTRUCTIONS. SHE STATES SHE GAVE HERSELF 24 UNITS OF NOVOLOG A COUPLE OF HOURS AGO AND HER BLOOD SUGAR REMAINED HIGH. I ASKED HER IF SHE HAS BEEN ILL OR HAS ANY SIGNS AND SYMPTOMS OF INFECTION. SHE STATES SHE HAS "KIDNEY PAIN" AND SHE HAS A HISTORY OF UTIS. SHE ALSO TOLD ME THAT HER INSERTION SITES ON HER ABDOMEN ARE RED AND ITCHY AND "LOOK LIKE PIMPLES". SHE DENIES THAT THERE IS ANY PUS COMING FROM THE SITES. SHE ALSO MENTIONED THAT SHE WAS EXPOSED TO A FAMILY MEMBER WHO DEVELOPED A (B)(6) INFECTION REQUIRING HOSPITALIZATION AND ANTIBIOTIC TREATMENT. I TOLD THE PT TO LEAVE HER PUMP OFF AND GO IMMEDIATELY TO THE EMERGENCY ROOM FOR HYDRATION, BLOOD GLUCOSE MGMT AND EVAL OF THE INSERTION SITES ON HER ABDOMEN. I ASKED HER TO CALL BACK WITH AN UPDATE AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMIGO INSULIN PUMP AMIGO LZG NIPRO DIABETES SYSTEMS, INC. 990004 11/01/2008

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention NOVOLOG 100 U/ML| GLUCOPRO SYRINGE: CAT # 994054