BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2943601 · Received February 5, 2013

    Report

    Report Number
    2531779-2013-01478
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. 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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 43MG/DL WITH MODERATE SHAKINESS. THE PATIENT REPORTEDLY WAS TREATED VIA ORAL CARBOHYDRATES AND HER BG ELEVATED TO 100MG/DL. THE PATIENT REPORTEDLY BOLUSED ACCORDING TO WHAT THE INSULIN TO CARBOHYDRATE (I:C) RATIO WAS SET TO ON THE PUMP PREVIOUSLY AND HAD BOLUSED 9.35 UNITS OF INSULIN. IT WAS NOTED THAT THE TARGET BG WAS SET TO 7AM INSTEAD OF THE TIME THE PATIENT BOLUSED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. USE ERROR CONTRIBUTED TO THE REPORTED EVENT BECAUSE THE PATIENT WAS BOLUSING ACCORDING TO THE I:C RATIO THAT WAS PREVIOUSLY PROGRAMMED BEFORE RESULTING IN THE WRONG TIME TO BOLUS; THEREFORE, SHE HAD GIVEN HERSELF AN OVERCORRECTION CAUSING HER BG TO GO LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48992 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening