BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2921321 · Received January 17, 2013

    Report

    Report Number
    2531779-2013-00833
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 26, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/09/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/25/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX STARTS ON (B)(6) 2015. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA/HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012, REPORTING THAT SHE BEGAN THE PUMP TWO MONTHS AGO AND EVER SINCE HAS BEEN HAVING LOW BLOOD GLUCOSE (BG) LEVELS RANGING FROM 40MG/DL TO 60MG/DL WITH FEELING MODERATE SHAKINESS, DIAPHORESIS AND TROUBLE CONCENTRATING. THE PATIENT TREATED HERSELF WITH GUMDROPS AND COKE AND 20 MINUTES LATER HER BG CAME UP TO TARGET RANGE. THE PATIENT STATED THAT HER HEALTHCARE PROFESSIONAL WAS MAKING ADJUSTMENTS SINCE (B)(6) 2012, FOR HER LOW BG'S. CUSTOMER SUPPORT (CS) COMPLETED TROUBLESHOOTING THE PUMP WITH THE PATIENT AND ALL SETTINGS WERE CORRECT. THE TOTAL DAILY DOSE, ISF, IC AND BOLUS HISTORY WERE CORRECT. THERE WERE NO RELEVANT ALARMS NOTED DURING TROUBLESHOOTING. CS CONFIRMED WITH THE PATIENT THERE WERE NO DISCREPANCIES FOUND IN THE PUMP AND INSULIN DELIVERED AS PROGRAMMED. CS ADVISED PATIENT TO FOLLOW UP WITH HER HEALTHCARE PROFESSIONAL FOR ADJUSTMENTS. THE PATIENT WAS NO ACTIVELY ADJUSTING RATES WITH THE BG EXCURSION. ALTHOUGH NO SPECIFIC EVIDENCE OF PUMP MALFUNCTION, DEFECT, OR MISUSE WAS DETECTED, THIS REPORT IS BEING MADE DUE TO THE POSSIBILITY THAT THE USE OF AN INSULIN PUMP MAY HAVE CONTRIBUTED IN AN UNIDENTIFIED MANNER TO THE BLOOD GLUCOSE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26590 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening