BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2183160 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05425
    Event Type
    Injury
    Date Received
    July 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) 2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(4) 2011 TO THE END OF PUMP USE ON (B)(4) 2011 SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29-HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. 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 PUMP ACCURATELY DELIVERS 2.00 UNITS/HR FOR 29-HR PERIOD.

    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

    THE PATIENT CALLED ANIMAS STATING THAT HER BLOOD GLUCOSE LEVELS WERE ELEVATED EVEN AFTER DELIVERING BOLUS DOSES. SHE SAYS THAT SHE ATE A ROAST BEEF SANDWICH THE DAY PRIOR TO CALLING ANIMAS AND GAVE HERSELF 11 UNITS OF HUMALOG INSULIN VIA MANUAL INJECTION. AT 3:15 PM HER BLOOD GLUCOSE LEVEL WAS REPORTEDLY 391 MG/DL AND AT 4:08 PM HER BLOOD GLUCOSE LEVEL REPORTEDLY ROSE TO 435 MG/DL AFTER DELIVERING THE BOLUS DOSE. SHE SAID SHE WENT TO THE DOCTOR'S OFFICE AT 12:40 PM EARLIER THAT DAY AND WAS TREATED WITH 38 UNITS OF LANTUS INSULIN. THE MORNING PRIOR TO CALLING ANIMAS SHE WAS AWAKENED BY HER CONTINUOUS BLOOD GLUCOSE MONITOR, WHICH ALARMED THAT HER BLOOD GLUCOSE LEVEL HAD BEEN ELEVATED. THE PUMP DISPLAY INDICATED THAT THE PUMP WAS DELIVERING INSULIN HOWEVER THE PATIENT ALLEGES THAT IT WAS NOT. AT NOON THAT DAY SHE CALLED HER DOCTOR WHO ADVISED HER TO TAKE HUMALOG INSULIN. SHE SAID HER BLOOD GLUCOSE LEVEL AT 2 PM WAS 583 MG/DL. THE PATIENT CALLED ANIMAS AT 2:46 PM. DURING THE CALL TO ANIMAS SHE SAID SHE FELT NAUSEOUS AND LETHARGIC. WHEN REVIEWING THE PUMP DURING TROUBLESHOOTING THE AMOUNTS DELIVERED IN THE PUMP HISTORY ADDED UP TO THE PROGRAMMED VALUES. THE PATIENT SAID SHE WAS NOT SEEING DROPS OF INSULIN COMING OUT OF THE INFUSION SET WHEN SHE TRIED TO DELIVER BOLUS DOSES. THE PATIENT'S HUMALOG INSULIN WAS CLEAR, STORED IN A REFRIGERATOR, AND WITHIN THE EXPIRATION DATE. SHE CONFIRMED HER PUMP INSULIN DELIVERY SETTINGS WERE CORRECT. THE ANIMAS REPRESENTATIVE ADVISED THE PATIENT TO CALL HER HCP TO REVIEW HER RECENT ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT WAS ALSO ADVISED TO REVIEW ANY SCAR TISSUE AT THE INFUSION SITE AND TO ROTATE HER INFUSION SITE AS PRECAUTIONARY MEASURES. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT ALLEGES HER BLOOD GLUCOSE LEVELS WERE ELEVATED AND THAT THE PUMP WAS NOT DELIVERING INSULIN APPROPRIATELY.

    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 48 YR