BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3212328 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-09912
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 09/18/2013 -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: INVESTIGATORS SUCCESSFULLY PERFORMED A 10U AUDIO AND 10U NORMAL BOLUS. BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE TOTAL DAILY DOSE ADDED UP CORRECTLY. THE PUMP PASSED A 29 HOUR FLOW ACCURACY TEST SUCCESSFULLY. THERE WERE NO ALARMS OCCURRED DURING TESTING. THE DISPLAY HAS A PINKISH CONTRAST. REMOVED COVER AND REPLACED PINK DISPLAY WITH TEST DISPLAY. THE TEST SCREEN IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF DISCOLORATION. INVESTIGATORS WERE UNABLE TO DUPLICATE THE REPORTED COMPLAINT. UNRELATED TO THE COMPLAINT, THE KEYPAD SYMBOLS WERE FOUND TO BE WORN.

    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. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR ( THE PATIENT INADEQUATELY NOT PRIMING THE PUMP AFTER A PUMP ALARM).

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013, WITH DIABETIC KETOACIDOSIS. THE REPORTER STATED THAT THEY DID NOT KNOW HOW HIGH THE BLOOD GLUCOSE (BG) WAS OR IF THE PATIENT HAD SYMPTOMS AT THE TIME OF ADMITTANCE. THE REPORTER STATED THAT THE PATIENT WAS TREATED WITH MANUAL INSULIN INJECTIONS. CUSTOMER SUPPORT (CS) REVIEWED THE BASAL HISTORY WITH THE REPORTER AND IT WAS DISCOVERED THAT THE PATIENT HAD RECEIVED AUTO OFF ALARM AND HAD NOT PRIMED THE PUMP AFTER RECEIVING THE ALARM AND DID NOT RECEIVE ANY INSULIN. THE PATIENT¿S FAMILY CALLED BACK AND PROVIDED ADDITIONAL INFORMATION. THE FAMILY MEMBER STATED THAT THE PATIENT¿S BG BEGAN TO RISE ON (B)(6) 2013 AND THE PATIENT¿S SYMPTOMS WERE OVER 600MG/DL OVER THE NEXT 1.5 DAYS. THE PATIENT¿S APPETITE WORSENED AND SEVERE TROUBLE BREATHING. THE PATIENT ALSO VOMITED ONCE BUT THIS WAS AFTER THE NEW KIDNEY MEDICATION OR THE ELEVATED BGS. THIS REPORT IS BEING MADE DUE TO THE PATIENT¿S ALLEGED HYPERGLYCEMIC EVENT THAT RESULTED FROM THE PATIENT INADEQUATELY NOT PRIMING THE PUMP AFTER A PUMP ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312170 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization