BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3140233 · Received May 31, 2013

    Report

    Report Number
    2531779-2013-07443
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    December 23, 2012
    Report Date
    May 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: EVALUATION REVEALED THAT THE LAST BASAL DELIVERY AND THE LAST BOLUS WERE RECORDED ON (B)(4) 2013. A MANUAL DATE AND TIME CHANGE WAS OBSERVED IN THE BLACK BOX FORM (B)(4) 2013 11:56 TO (B)(4) 2013 13:21. THE TOTAL DAILY DOSES ADD UP CORRECTLY TO REFLECT THE USERS PROGRAMMED BASAL RATES. THERE WERE NO ALARMS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY, ONLY TYPICAL USAGE WAS OBSERVED. THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION AT THE CONCLUSION OF THE 29 HOUR FLOW ACCURACY TEST. THE COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION.

    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 FOR AN UNRELATED ISSUE AND MENTIONED THAT IN (B)(6) OF 2012, SHE WENT TO THE ER WITH ELEVATED BLOOD GLUCOSE (BG) OF 400MG/DL AND WAS THEN TRANSFERRED TO ANOTHER HOSPITAL DUE TO CHEST PAIN AND A MYOCARDIAL INFARCTION (MI). THE PATIENT WAS REPORTEDLY TREATED IN THE CRITICAL CARE UNIT FROM (B)(6) 2012. THE PATIENT REPORTEDLY HAS A HISTORY OF ARTHRITIS, CARDIAC DISEASE WITH STENTS, CHRONIC GASTRITIS, GERD, ANEMIA, AND HYPOTHYROIDISM. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE PATIENT AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT. TROUBLESHOOTING DETERMINED THAT THE PUMP WAS DELIVERING AS PROGRAMMED. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WITH CARDIAC ISSUES, AND IT COULD NOT BE DETERMINED IF THE PATIENT¿S ONGOING CARDIAC ISSUES CAUSED THE BG ELEVATION OR IF THE BG ELEVATION WAS A CAUSE OR CONTRIBUTOR TO THE CHEST PAINS AND MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242477 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR