BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2922251 · Received January 18, 2013

    Report

    Report Number
    2531779-2013-00847
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 19, 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 HAD TWO EMERGENCY ROOM (ER) VISITS WITHIN THE PAST WEEK. THE REPORTER NOTED THAT ON (B)(6) 2012 THE PATIENT WAS TAKEN TO THE NURSE'S OFFICE AT SCHOOL DUE TO CONFUSION, AND HIS BLOOD GLUCOSE (BG) TESTED AT 51MG/DL. THE REPORTER NOTED THAT THIS BG VALUE IS NOT NECESSARILY CONSIDERED LOW FOR THE PATIENT. THE REPORTER STATED THAT THE PATIENT WAS CONFUSED AND DIAPHORETIC AND THE PATIENT'S DOCTOR RECOMMENDED THE PATIENT BE TAKEN TO THE ER. THE REPORTER NOTED THAT THE PATIENT WAS AWAKE AND TALKING, BUT HE DOES NOT REMEMBER APPROXIMATELY 40 MINUTES OF TIME DURING THE INCIDENT. THE REPORTER STATED THAT THE SCHOOL NURSE HAD TREATED THE PATIENT'S BG AND BY THE TIME THE PATIENT GOT TO THE ER HIS BG WAS 100MG/DL. THE REPORTER STATED THAT THE PATIENT DID NOT RECEIVE ANY MEDICATIONS IN THE ER. SHE NOTED THAT THE PATIENT'S BG WAS MONITORED AND THE PATIENT HAD A HEAD CT TO RULE OUT SEIZURE. THE REPORTER STATED THAT A SIMILAR INCIDENT OCCURRED THE WEEK PRIOR AS WELL. AT THAT TIME, THE PATIENT'S BG WAS 140MG/DL AND THE PATIENT WAS TALKING BUT WAS NOT MAKING SENSE, AND HE STATED THAT HE "FELT STRANGE". THE INCIDENT THAT OCCURRED ON (B)(6) 2012 WAS REPORTEDLY A LONGER INCIDENT AND THE PATIENT DID NOT RECALL SPEAKING WITH THE SCHOOL NURSE DURING THAT INCIDENT. THE REPORTER STATED THAT THE MD IN THE ER BELIEVED THAT THE INCIDENTS WERE DUE TO A "LOW BG REACTION" AND ORDERED A NEUROLOGICAL CONSULT AND AN MRI. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL AND WAS DISCHARGED. THE REPORTER STATED THAT NEITHER SHE NOR THE PATIENT'S PRIMARY CARE PHYSICIAN (PCP) BELIEVED THE INCIDENTS WERE RELATED TO LOW BGS, AND THE REPORTER STATED SHE THOUGHT THERE WAS SOMETHING ELSE MEDICALLY GOING ON TO CAUSE THE INCIDENTS. THE REPORTER DECLINED TO REVIEW THE PUMP, STATING THAT SHE WAS NOT IMPLICATING THE PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO THE ER MD'S ALLEGATION THAT THE REPORTED INCIDENTS WERE RELATED TO HYPOGLYCEMIA AND THE PUMP COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE REPORTED INCIDENTS SINCE THE REPORTER DECLINED TO TROUBLESHOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27272 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

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