BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2922175 · Received January 18, 2013

    Report

    Report Number
    2531779-2013-00842
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    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: A REVIEW OF THE BLACK BOX HISTORY REVEALED THE LAST BASAL DELIVERY WAS ON (B)(4) 2013 AND A BASAL DELIVERY INTERRUPTION WAS OBSERVED ON (B)(4) 2013 DUE TO AN UNACKNOWLEDGED ALARM CODE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE WITHIN SPECIFICATION. THE "EZ-PRIME" STEPS WERE SUCCESSFULLY PERFORMED ON THE PUMP WITH NO ISSUES. THE PUMP EXERCISED FOR 24 HOURS WITH NO ALARMS NOTED. THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE COVER WAS REMOVED, NO INTERMITTENT CONDITION OR MOISTURE INGRESS WAS OBSERVED TO THE FORCE SENSOR CIRCUIT OR TO THE POWER CIRCUIT

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS STATING THAT ON (B)(6) 2012, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 600MG/DL. THE PATIENT REPORTEDLY FELT "ILL" AND EXPERIENCED SYMPTOMS OF VOMITING, STOMACH PAIN, THIRST AND INCREASED URINATION. THE PATIENT REPORTEDLY HAD A MEASUREMENT OF 80MG/DL WHEN SHE TESTED FOR KETONES AND WENT TO THE HOSPITAL. THE PATIENT'S BG REPORTEDLY WAS 690MG/DL UPON ARRIVAL AT THE HOSPITAL AND WAS TREATED VIA (IV) INTRAVENOUS DRIP WHEN SHE WAS STILL CONNECTED TO THE PUMP. IT WAS NOTED LATER ON THE PATIENT WAS REMOVED OFF THE PUMP AND CONTINUED IV TREATMENT. THE PUMP REPORTEDLY WAS REVIEWED BY A HOSPITALIST AT THE HOSPITAL AND NOTED THAT THE PUMP'S SCREEN WAS BLANK BUT THE PUMP'S VIBRATORY FEATURE AND SOUND WAS STILL WORKING. THERE WERE REPORTEDLY NO FURTHER ISSUES WITH THE PUMP, THE PATIENT'S BG LEVELS RETURNED TO NORMAL AND THE PATIENT WAS FEELING BETTER. THE REPORTER STATED THAT THE PATIENT WAS NOT USING THE PUMP CORRECTLY BECAUSE SHE WAS NOT TESTING HER BG LEVELS, HE WAS UNSURE IF SHE WAS BOLUSING, SHE WAS NOT USING THE METER REMOTE AND WAS USING A DIFFERENT DEVICE TO MONITOR HER BG. THE REPORTER DENIED DAMAGE TO THE PUMP AND WAS NOT IMPLICATING THE PUMP AS A CONTRIBUTING FACTOR FOR THE CAUSE OF THE PATIENT'S BG EVENT. CUSTOMER SUPPORT (CS) WAS UNABLE TO REVIEW THE PUMP WITH THE PATIENT DUE TO THE PATIENT BEING AWAY FOR COLLEGE. THE PATIENT REPORTEDLY DISCONTINUED PUMP THERAPY. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. IT WAS UNCLEAR AS TO WHETHER OR NOT THE PUMP AND/OR USE ERROR CONTRIBUTED TO THE REPORTED BG EXCURSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28036 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R