BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4632101 · Received March 25, 2015

    Report

    Report Number
    2531779-2015-09917
    Event Type
    Injury
    Date Received
    March 25, 2015
    Report Date
    March 10, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/20/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED A LOSS OF PRIME WARNING ASSOCIATED WITH A LOW NON-ZERO FORCE ON (B)(6) 2015. THERE WERE NO LOAD STEP MALFUNCTIONS OR LARGE PRIME VALUES OBSERVED IN THE PUMP HISTORY. A FULL CARTRIDGE WAS ABLE TO BE LOADED IN THE PUMP WITH NO ERRORS. A 24HR DURATION TEST WAS SUCCESSFULLY COMPLETED WITH NO LOSS OF PRIME WARNINGS BEING DUPLICATED. THE FORCE SENSOR CALIBRATION CHECK SHOWED THAT THE PUMP WAS DETECTING THE CORRECT FORCE. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. 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 REQUESTED TO BE 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. USE ERROR SHOULD BE CONSIDERED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 274 MG/DL WITH A "WOOZY" FEELING, NAUSEA, AND CONFUSION. REPORTEDLY, THE PATIENT REMAINED ON THE INSULIN PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. IT WAS REPORTED THAT WHEN LOADING THE CARTRIDGE, THE PUMP SCREEN READ 162-165 UNITS REMAINING IN CARTRIDGE AFTER FILLING THE CARTRIDGE TO 2.0ML MARKING. REPORTEDLY, THE PUMP WAS NOT PRIMING DURING THE LOAD STEP. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS DETERMINED THAT THIS WAS DUE TO TRAINING /MISUSE. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO PATIENT ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200071 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR