BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2800240 · Received October 22, 2012

    Report

    Report Number
    2531779-2012-12603
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 UNEXPLAINED HIGH AND LOW BLOOD GLUCOSE (BG) EXCURSIONS. THE PATIENT REPORTED THAT HE HAD BEEN HAVING HIGH AND LOW BGS FOR THE LAST MONTH. THE PATIENT STATED THAT ON THE LATE EVENING OF (B)(6) 2012 (11:45PM), HIS SPOUSE FOUND HIM ON THE BED SEMI-UNCONSCIOUS. SHE IMMEDIATELY CONTACTED EMERGENCY SERVICES AND WHEN THEY ARRIVED AND TESTED HIS BLOOD GLUCOSE IT WAS 25 OR 26 MG/DL. THE PATIENT CLAIMED HE WAS TRANSPORTED VIA AMBULANCE TO THE HOSPITAL ABOUT 12:30AM AND WAS ADMITTED WITH A BG OF 33 MG/DL. THE PATIENT REPORTED HE WAS DISCHARGED ON (B)(6) 2012 BUT DID NOT RESUME PUMP THERAPY UNTIL (B)(6) 2012. AT THE TIME OF THE CALL, THE PATIENT ALSO REPORTED THAT HIS BG HAD ALSO GONE AS HIGH AS THE 300'S MG/DL WITH SYMPTOMS OF FREQUENT URINATION AND THIRST. THE PATIENT CLAIMED HE WOULD GIVE HIMSELF A CORRECTIONAL BOLUS IN RESPONSE TO THE HIGH BG. AT THE TIME OF TROUBLESHOOTING, THE PATIENT INFORMED ANIMAS CUSTOMER SUPPORT THAT ON THE EVENING PRIOR HIS SPOUSE NOTICED THAT THE AM/PM WAS SET INCORRECTLY. AT THE TIME OF THE CALL, THE PATIENT CLAIMED HE MAY HAVE CHANGED THE TIME SETTING ON THE PUMP INADVERTENTLY. DURING THE CALL, THE PATIENT REMOVED AND REINSERTED THE PUMP'S BATTERY TO REBOOT THE PUMP AND CONFIRMED THE PUMP'S CURRENT DATE AND TIME WERE MAINTAINED. CUSTOMER SUPPORT THEN ADVISED PATIENT TO REVIEW BASAL RATES SET IN THE PUMP. CUSTOMER SUPPORT NOTED THAT THE BASAL RATES RANGE WERE SO CLOSE TO EACH OTHER (0.800 TO 0.850) THAT THE INCORRECT TIME (AM/PM SETTING) WOULD NOT HAVE CAUSED A SEVERE HYPOGLYCEMIC EPISODE. REVIEW OF BASAL HISTORY INDICATED THAT TDD (TOTAL DAILY DELIVERY) BASAL WAS CORRECT. THE PATIENT CONFIRMED ALL OTHER SETTINGS WERE ALSO CORRECT. THERE WERE NO ASSOCIATED ALARMS IN HISTORY. THE PATIENT DENIED ANY UNUSUAL ACTIVITY IN BOLUS HISTORY. THE PATIENT DENIED ANY CHANGES TO HIS DIET, ACTIVITY LEVEL OR MEDICATIONS. AFTER REVIEWING THE PUMP HISTORY AND SETTINGS, ANIMAS CUSTOMER SUPPORT ADVISED THE PATIENT.

    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 57 YR Hospitalization| L| R