BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2981464 · Received February 27, 2013

    Report

    Report Number
    2531779-2013-02227
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE ARE NO ALARMS OR WARNINGS OBSERVED IN THE PUMP HISTORIES RELATED TO THE COMPLAINT. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. A 10UNIT AUDIO BOLUS AND A NORMAL 10UNIT BOLUS WERE SUCCESSFULLY PERFORMED AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORIES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE KEYPAD BUTTONS WERE INSPECTED AND NO HYPERSENSITIVITY WAS OBSERVED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. 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. INVESTIGATION ALSO REVEALED THE PUMP WAS NOT VIBRATING UPON POWERING UP. THE PUMP COVER WAS REMOVED AND EXAMINATION SHOWED THAT THE VIBRATION MOTOR PINS WERE NOT MAKING A CONNECTION WITH THE PCB.

    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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT HER SON HAD A BLOOD GLUCOSE (BG) OF 600MG/DL TODAY AND WAS FEELING "HYPER". THEY GAVE MULTIPLE BOLUSES VIA THE PUMP AND TOOK A LONG TIME TO GET HIM TO COME DOWN, STATED THAT HE DOES HAVE KETONES AND THAT THEY ARE ALSO PUSHING FLUIDS, MOM IS TO CALL BACK WHEN PATIENT IS HOME FROM SCHOOL TO FURTHER TROUBLESHOOT THE ISSUE. PATIENT IS CURRENTLY ON PUMP AND AT SCHOOL AT THIS TIME AND BG IS WITHIN TARGET. MOM CALLED BACK WHEN SON WAS HOME FROM SCHOOL TO TROUBLE SHOOT THE PUMP. CUSTOMER TECHNICAL SUPPORT (CTS) FOUND NO ISSUES: TIME AND DATE ARE CORRECT, NO ALARMS, TDD CORRECT, BOLUS AND PRIME HISTORIES CORRECT, ADVANCED FEATURES SET AS DESIRED, BASALS CORRECT. MOM REPORTS PATIENT IS NOT ILL AND INFUSION SET HAS BEEN CHANGED AND INSULIN WAS OPENED ONE WEEK AGO. MOM REPORTS BG'S ARE GOOD FOR A FEW DAYS THEN RUN VERY HIGH THEN DROP FAST THE NEXT DAY. RIGHT NOW BG IS 362 MG/DL UP FROM 294 MG/DL 30 MINUTES AGO. MOM HAS GIVEN INJECTION BOLUS WHILE ON THIS CALL, AND PUMP HAS BEEN DISCONNECTED WHILE TROUBLESHOOTING. MOM IS INSISTING PUMP BE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON PUMP THERAPY DEVELOPED HYPERGLYCEMIA RELATED TO AN UNSPECIFIED PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84785 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening