BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2960827 · Received February 14, 2013

    Report

    Report Number
    2531779-2013-01770
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (IMPROPER TREATMENT MANAGEMENT AS THE PATIENT ADMITTEDLY DOUBLE BOLUSED).

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT ON (B)(6) 2013 HE PROGRAMMED A 7-8 UNIT BOLUS BUT THEN THOUGHT IT GOT CANCELED RELATED TO AN EMPTY CARTRIDGE ALARM. THE PATIENT STATED THAT HE FILLED THE CARTRIDGE AND THEN PROGRAMMED ANOTHER 7-8 UNIT BOLUS SO HE THOUGHT HE MIGHT HAVE GOTTEN TWICE AS MUCH INSULIN AS HE SHOULD. THE PATIENT STATED THAT HE HAS BEEN HAVING BLOOD GLUCOSE (BG) LEVELS OF HIGH 400'S MG/DL. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. AND THE PATIENT ALSO EXPERIENCED LOW BG'S OF 24 MG/DL. THE PATIENT STATED THAT HE WAS TAKEN TO THE HOSPITAL VIA AMBULANCE. HE STATED THAT HE WAS TREATED AND RELEASED AND NEVER ADMITTED TO THE HOSPITAL. THE PATIENT WAS UNSURE OF WHAT WAS GIVEN TO HIM. THE PATIENT STATED THAT HE IS ON A LOW DOSE ANTIBIOTIC RELATED TO (B)(6) AND HE IS NOT TAKING ANY OTHER MEDICATIONS AND THIS IS WHY HE WAS AT THE HOSPITAL. THE PATIENT ALSO REPORTED THAT HIS PUMP WAS NOT DELIVERING INSULIN THAT DAY BECAUSE HE HAD IGNORED A LOW CARTRIDGE ALARM. THERE WERE NO ISSUES WITH THE PUMP. THE PATIENT STATED THAT HE HAD A BAD INFECTION NOT RELATED TO THE PUMP AND HAS CAUSED SOME ISSUES WITH ELEVATED BG BUT NOT PUMP RELATED. THE PATIENT REQUESTED THAT ALL TELEPHONE CALLS STOP BECAUSE THERE IS NO ISSUE WITH THE PUMP AND WILL CALL IN THE FUTURE IF HE REQUIRES ASSISTANCE. THE PATIENT CONTINUES TO USE THE PUMP. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPOGLYCEMIC EVENT THAT RESULTED FROM IMPROPER TREATMENT MANAGEMENT AS THE PATIENT ADMITTEDLY DOUBLE BOLUSED IN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64688 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization