BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4690396 · Received April 14, 2015

    Report

    Report Number
    2531779-2015-12512
    Event Type
    Injury
    Date Received
    April 14, 2015
    Date of Event
    April 3, 2015
    Report Date
    April 3, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 06/09/2016: 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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/27/2016 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED RECORDS BEGINNING ON (B)(6) 2016. DATA FROM THE DATE OF THE ALLEGED EVENT HAD BEEN OVERWRITTEN DUE TO CONTINUED PATIENT USE. THE AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. ON INVESTIGATION, THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED RANGE AND DELIVERING ACCURATELY. INVESTIGATION DID NOT DUPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2015 ALLEGING HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY WITH BLOOD GLUCOSE MEASUREMENT OF 38 MG/DL WITH UNSTEADINESS WHEN STANDING AND WALKING. THE REPORTER CONFIRMED THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES MANAGEMENT. TROUBLESHOOTING BY ANIMAS CUSTOMER SUPPORT DETERMINED THERE WAS NO PUMP MALFUNCTION, HOWEVER, THERE WAS A TRAINING/MISUSE ISSUE; USER MISCOUNTING CARBOHYDRATES, BOLUS TYPE WAS INCORRECTLY PROGRAMMED. THE USER TOOK 4.3 UNITS OF U 500 INSULIN VIA THE INSULIN PUMP WHEN BLOOD GLUCOSE (BG) WAS AT 88 MG/DL. USER¿S TARGET BG WAS REPORTED TO BE 130-150 MG/DL. USER USING INCORRECT TYPE OF INSULIN THE PUMP PER THE USER¿S BOOKLET; YOUR PUMP IS DESIGNED AND CALIBRATED TO DELIVER U100 INSULIN. USE OF ANY INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN SERIOUS INJURY OR DEATH. INCORRECT USE OF YOUR PUMP, FAILURE TO FOLLOW THE INSTRUCTIONS IN THIS OWNER¿S BOOKLET OR IMPROPER/INADEQUATE SELF-CARE AND TROUBLESHOOTING TECHNIQUES CAN LEAD TO DEATH OR SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER EXPERIENCED HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY DUE TO TRAINING/MISUSE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247786 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR