BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2890340 · Received December 29, 2012

    Report

    Report Number
    2531779-2012-15228
    Event Type
    Injury
    Date Received
    December 29, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/16/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGINS ON 03/20/2014. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT ON (B)(6) 2012 HAVE BEEN OVERWRITTEN. THE CURRENT PUMP HISTORY SHOWS NO EAW¿S RELATED TO THE COMPLAINT. DAILY INSULIN DELIVERY TOTALS WERE FOUND TO CORRECTLY REFLECT THE USER'S PROGRAMMED BASAL RATES. THE PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. 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 REPORTER CONTACTED ANIMAS ON (B)(6) 2012 STATING THE PATIENT WAS IN THE HOSPITAL EMERGENCY ROOM AT THE TIME OF THE CALL WITH NAUSEA, VOMITING AND KETONES. THE REPORTER STATED THE PATIENT HAD ELEVATED BLOOD GLUCOSE (BG) IN THE 200 MG/DL RANGE INTERMITTENTLY THE PRIOR DAY AND CONSISTENTLY THROUGHOUT THE PREVIOUS NIGHT WITH THE HIGHEST BG 280 MG/DL. THE REPORTED STATED THE EMERGENCY ROOM PHYSICIAN WAS UNCERTAIN IF THE PATIENT HAD A STOMACH VIRUS OR IF THE VOMITING WAS THE RESULT OF ELEVATED BG. THE REPORTER STATED THAT BG IN THE 200 MG/DL RANGE WAS NOT UNUSUAL FOR THIS PATIENT, BUT IT WAS UNUSUAL FOR THE BG TO BE CONSISTENTLY IN THE 200 MG/DL RANGE. AT THE TIME OF THE CALL TO ANIMAS, THE PATIENT'S BG WAS REPORTEDLY 225 MG/DL. THE PATIENT REPORTEDLY RECEIVED IV FLUIDS, NAUSEA MEDICATION AND 3.50 UNITS OF INSULIN VIA SYRINGE WHILE IN THE EMERGENCY ROOM. THE REPORTER STATED THE PATIENT'S INFUSION SITE WAS CHANGED THE PRIOR NIGHT AND THE EMERGENCY ROOM PHYSICIAN WILL HAVE THE SITE CHANGED AGAIN AS A PRECAUTION TO RULE OUT ANY ISSUE WITH THE INFUSION SITE; HOWEVER, AT THE TIME OF THE CALL, THERE WAS NO KNOWN INFUSION SIDE ISSUE. THE REPORTER STATED THAT THE PATIENT WILL REPORTEDLY CONTINUE ON INSULIN PUMP THERAPY. TROUBLESHOOTING BY ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) WAS UNABLE TO REVEAL ANY DEFECT WITH THE INSULIN PUMP. THE REPORTER DENIED ANY ISSUES WITH THE INSULIN BEING USED IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT RECEIVED MEDICAL INTERVENTION AT THE EMERGENCY ROOM FOR ELEVATED BLOOD GLUCOSE OF UNKNOWN ORIGIN WHILE ON INSULIN PUMP THERAPY USING A PUMP WITH NO MALFUNCTION. ACTS DETERMINED THE PATIENT'S ELEVATED BG WAS DUE TO OTHER HEALTH CONDITIONS.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 STATING THE PATIENT WAS IN THE HOSPITAL EMERGENCY ROOM AT THE TIME OF THE CALL WITH NAUSEA, VOMITING AND KETONES. THE REPORTER STATED THE PATIENT HAD ELEVATED BLOOD GLUCOSE (BG) IN THE 200 MG/DL RANGE INTERMITTENTLY THE PRIOR DAY AND CONSISTENTLY THROUGHOUT THE PREVIOUS NIGHT WITH THE HIGHEST BG 280 MG/DL. THE REPORTED STATED THE EMERGENCY ROOM PHYSICIAN WAS UNCERTAIN IF THE PATIENT HAD A STOMACH VIRUS OR IF THE VOMITING WAS THE RESULT OF ELEVATED BG. THE REPORTER STATED THAT BG IN THE 200 MG/DL RANGE WAS NOT UNUSUAL FOR THIS PATIENT, BUT IT WAS UNUSUAL FOR THE BG TO BE CONSISTENTLY IN THE 200 MG/DL RANGE. AT THE TIME OF THE CALL TO ANIMAS, THE PATIENT'S BG WAS REPORTEDLY 225 MG/DL. THE PATIENT REPORTEDLY RECEIVED IV FLUIDS, NAUSEA MEDICATION AND 3.50 UNITS OF INSULIN VIA SYRINGE WHILE IN THE EMERGENCY ROOM. THE REPORTER STATED THE PATIENT'S INFUSION SITE WAS CHANGED THE PRIOR NIGHT AND THE EMERGENCY ROOM PHYSICIAN WILL HAVE THE SITE CHANGED AGAIN AS A PRECAUTION TO RULE OUT ANY ISSUE WITH THE INFUSION SITE; HOWEVER, AT THE TIME OF THE CALL, THERE WAS NO KNOWN INFUSION SIDE ISSUE. THE REPORTER STATED THAT THE PATIENT WILL REPORTEDLY CONTINUE ON INSULIN PUMP THERAPY. TROUBLESHOOTING BY ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) WAS UNABLE TO REVEAL ANY DEFECT WITH THE INSULIN PUMP. THE REPORTER DENIED ANY ISSUES WITH THE INSULIN BEING USED IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT RECEIVED MEDICAL INTERVENTION AT THE EMERGENCY ROOM FOR ELEVATED BLOOD GLUCOSE OF UNKNOWN ORIGIN WHILE ON INSULIN PUMP THERAPY USING A PUMP WITH NO MALFUNCTION. THE PUMP IS NOT BEING RETURNED TO ANIMAS FOR INVESTIGATION. ACTS DETERMINED THE PATIENT'S ELEVATED BG WAS DUE TO OTHER HEALTH CONDITIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR