BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2840763 · Received November 20, 2012

    Report

    Report Number
    2531779-2012-13807
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT SHE WAS HOSPITALIZED ON (B)(6) 2012 FOR A HIGH BLOOD GLUCOSE (BG) EXCURSION. NO ADDITIONAL INFORMATION REGARDING THAT HOSPITALIZATION WAS PROVIDED. THE PATIENT CALLED ANIMAS AGAIN ON (B)(6) 2012 AND ALSO REPORTED SHE HAD BEEN HOSPITALIZED AGAIN FOR A HIGH BG AND WAS IN ICU. THE PATIENT MENTIONED AT TIME OF ADMISSION SHE WAS DISCONNECTED FROM PUMP AND STARTED ON AN INSULIN DRIP. THE PATIENT STATED HER BG WENT HIGHER AFTER BEING STARTED ON THE INSULIN DRIP. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT. THE PATIENT INFORMED ANIMAS CUSTOMER SUPPORT THAT SHE DID NOT WANT TO CONTINUE ON THE PUMP AND WANTED TO GO BACK ON INJECTIONS. CUSTOMER SUPPORT NOTED THEY ADVISED THE PATIENT'S DOCTOR'S OFFICE OF REQUEST. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO REACH PATIENT BY PHONE TO REVIEW PUMP REGARDING HIGH BGS; HOWEVER, WERE UNSUCCESSFUL IN THEIR ATTEMPTS. DURING CALL TO CUSTOMER SUPPORT ON (B)(6) 2012, THE PATIENT INFORMED CUSTOMER SUPPORT THAT HER BG HAD BEEN 250MG/DL WHEN SHE WOKE UP ON MONDAY. THE PATIENT STATED INSTEAD OF CORRECTING FOR THE ELEVATED BG SHE WENT BACK TO BED AND WOKE UP WITH A HIGHER BG (RESULT NOT PROVIDED). THERE WAS NO MENTION OF SYMPTOMS. DURING THE CALL, THE PATIENT MENTIONED THAT SHE BELIEVES SHE MAY HAVE FORGOTTEN TO FILL THE CANNULA WHEN SHE CHANGED OUT HER INFUSION SET. IT IS NOT KNOWN WHEN THE PATIENT CHANGED OUT HER INFUSION SET PRIOR TO HER HOSPITALIZATION ON (B)(6) 2012. DURING CALL TO CUSTOMER SUPPORT ON (B)(6) 2012, THE PATIENT DID NOT PROVIDE ANY BG VALUES; HOWEVER, STATED WHEN SHE BOLUSED IN RESPONSE TO AN ELEVATED BG HER BG WENT HIGHER. THE PATIENT CLAIMED WHEN THE INFUSION SET WAS REMOVED IT WAS NOT KINKED. CUSTOMER SUPPORT NOTED THAT THE PATIENT REPORTED NOT WANTING TO CONTINUE WITH PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS HOSPITALIZED ON TWO SEPARATE OCCASIONS FOR HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY. BASED ON THE INFORMATION PROVIDED, IT APPEARS THAT THE PATIENT'S HYPERGLYCEMIA COULD BE ATTRIBUTED TO USE ERROR. THE PATIENT REPORTED THAT SHE DID NOT TREAT FOR A HIGH BLOOD GLUCOSE AS RECOMMENDED. IN ADDITION, THE PATIENT MENTIONED THE HIGH BG MAY HAVE ALSO BEEN AS A RESULT OF NOT FILLING THE CANNULA AFTER HAVING CHANGED OUT HER INFUSION SET.

    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 50 YR Hospitalization| L| R