BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2201293 · Received August 11, 2011

    Report

    Report Number
    2531779-2011-05791
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. A TEST BATTERY CAP WAS USED DURING TESTING. EVALUATION CONFIRMED THAT THE BATTERY COMPARTMENT WAS CRACKED. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP. A REVIEW OF THE PUMP HISTORY SHOWED SEVERAL UNEXPLAINED REBOOTS. THE BATTERY CAP WOULD NOT TIGHTEN APPROPRIATELY, AND THE PUMP WOULD RESET IF THE CAP WAS TURNED. THE PUMP PASSED FLOW ACCURACY TESTING WITH NO INSULIN DELIVERY ISSUES OCCURRING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE OK KEYPAD BUTTON WAS INTERMITTENTLY UNRESPONSIVE. ALL OTHER KEYPAD BUTTONS WERE FUNCTIONING APPROPRIATELY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER THE BUTTON KEY CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER CONTACTED ANIMAS ALLEGING THE PUMP HAS BEEN SELF-REBOOTING FOR THE PAST MONTH AND A HALF. THE REPORTER DENIED THAT THE PATIENT DEVELOPED SYMPTOMS OF NAUSEA, VOMITING, OR SHORTNESS OF BREATH; HOWEVER, CLAIMED THAT THE PATIENT HAS HAD HIGH BLOOD GLUCOSE (BG) READINGS IN THE 500'S MG/DL RANGE SINCE THE ISSUE STARTED. THE PATIENT'S MOTHER WAS UNABLE TO PROVIDE DATES OF HIGH BG READINGS. SHE REPORTED THAT THE HIGH BG'S WOULD USUALLY OCCUR IN THE MORNINGS AFTER THE PATIENT DISCOVERED PUMP WAS OFF WHEN HE WOKE UP. AT THE TIME OF TROUBLESHOOTING, THE REPORTER CONFIRMED WHEN THE PUMP REBOOTED, THE PATIENT WOULD OBTAIN THE VERIFY SCREEN AND WOULD COMPLETE THE REWIND, LOAD AND PRIME STEPS. THE PATIENT CONFIRMED HE REPLACED THE PUMP'S BATTERY CAP 1 MONTH PRIOR TO CONTACTING ANIMAS, BUT REPORTED THERE WAS A VISIBLE CRACK ON PUMP'S BATTERY COMPARTMENT.

    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 13 YR Life Threatening