BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3041419 · Received April 8, 2013

    Report

    Report Number
    2531779-2013-03800
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE HISTORY SHOWS THE LAST BOLUS AND THE LAST BASAL WERE RECORDED ON (B)(6) 2013. THE BLACK BOX FOR THE EVENT ON (B)(6) 2013 HAS BEEN OVERWRITTEN. THE BOLUS HISTORY SHOWS NO BOLUSES WERE GIVEN ON THE (B)(6) 2013. THE TOTAL DAILY DOSE FOR THAT DAY WERE LOW. THE ALARM HISTORY SHOWS AN AUTO TIMEOUT PUMP SUSPENDED ON (B)(4) 2013. THE NEXT PRIME RECORDED ON (B)(4) 2013. THE PUMP SUCCESSFULLY COMPLETED THE REQUIRED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLIANT DURING THE INVESTIGATION. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE HAS BEEN HAVING ISSUES WITH LOW BLOOD GLUCOSE (BG) IN THE EVENINGS. THE PATIENT NOTED THAT THE EVENING OF (B)(6) 2013, SHE EXPERIENCED BG OF 29MG/DL WITH CONFUSION AND BELLIGERENCE, AND STATED THAT SHE WAS COMBATIVE. THE PATIENT STATED THAT FAMILY MEMBER ADMINISTERED GLUCAGON. THE PATIENT COULD NOT EXPLAIN THE RECENT ISSUES WITH LOW BG AND WANTED TO TROUBLESHOOT THE PUMP. CUSTOMER TECHNICAL SUPPORT (CST) REVIEWED THE PUMP WITH THE PATIENT AND FOUND ALL SETTINGS AND HISTORIES ARE CORRECT. THE PATIENT NOTED THAT HER DOCTOR RECENTLY ADJUSTED SETTINGS DUE TO THE LOW BGS AND SHE CONFIRMED THE CURRENT SETTINGS ARE CORRECT. THERE WAS NO PUMP DEFECT FOUND UPON TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPOGLYCEMIA OF UNKNOWN CAUSE REQUIRING ASSISTANCE OF ANOTHER PERSON WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143778 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening| R