BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2922326 · Received January 18, 2013

    Report

    Report Number
    2531779-2013-00848
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 27, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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) 2012, THE REPORTER CONTACTED ANIMAS FOR AN UNRELATED ISSUE AND MENTIONED THAT THE PATIENT'S BLOOD GLUCOSE (BG) HAS BEEN "ALL OVER THE PLACE". THE REPORTER STATED THAT THE PATIENT'S BG ELEVATES OVER 300MG/DL AT TIMES WITH NAUSEA VOMITING, AND KETONES. THE REPORTER ALSO MENTIONED THAT ON THE MORNING OF (B)(6) 2012 THE PATIENT EXPERIENCED A BG OF 41MG/DL AND WAS DIFFICULT TO WAKE UP. THE REPORTER STATED SHE COULD NOT GET THE PATIENT TO DRINK AND SHE GAVE THE PATIENT GLUCAGON AND CALLED 911. THE REPORTER NOTED THAT THE PATIENT WAS NOT COMBATIVE AND KNEW WHO SHE WAS DURING THE INCIDENT. THE REPORTER STATED THAT THE PATIENT'S BG WAS UP TO 95MG/DL WHEN THE PARAMEDICS ARRIVED AND THE PATIENT WAS NOT TRANSPORTED TO THE HOSPITAL. THE REPORTER STATED THAT THE PATIENT CHECKS HIS BG EIGHT TO TEN TIMES PER DAY, AND ALSO NOTED THAT THE PATIENT IS GOING THROUGH SOME HORMONAL CHANGES. THE REPORTER STATED THAT THEY HAVE MADE SETTINGS ADJUSTMENTS AND ARE CONTINUING TO WORK WITH THE PATIENT'S DOCTOR ON SETTINGS ADJUSTMENTS. THE REPORTER DECLINED TO REVIEW THE PUMP, STATING SHE DID NOT IMPLICATE THE PUMP IN THE REPORTED ERRATIC BGS. THE PATIENT REPORTEDLY HAD AN MRI THE EVENING OF (B)(6) 2012 RELATED TO ONGOING ISSUES THAT THE REPORTER BELIEVES ARE NOT BG-RELATED, AND THE MRI RULED OUT COMPLEX SEIZURE. THE PATIENT REPORTEDLY HAS AN OFFICE APPOINTMENT TO MEET WITH A NEUROLOGIST. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT HAS EXPERIENCED UNEXPLAINED HYPERGLYCEMIA AND HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY, AND THE PUMP CANNOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR AS THE REPORTER DECLINED TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28196 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening| R