BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2172030 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05117
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1, (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(6) 2011 TO END OF PUMP USE ON (B)(6) 2011 CONFIRMED THAT DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT 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

    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. (B)(6).

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THE FOLLOWING SEQUENCE OF EVENTS RESULTING IN EMERGENCY ROOM TREATMENT OF ELEVATED BLOOD GLUCOSE (BG). SHE SAID THAT THE PATIENT'S BG BEGAN TO ELEVATE AFTER SCHOOL ON (B)(6) 2011. THE PATIENT HAD BEEN PLAYING OUTSIDE AND THE CANNULA CAME LOOSE FROM THE SITE. THE PATIENT REPORTEDLY INSERTED A NEW SET ON HIS OWN. DURING THE NIGHT THE PATIENT'S BG ELEVATED TO 600 MG/DL (HI ON HIS METER); HE HAD MODERATE KETONES, NAUSEA, AND EMESIS. THE PATIENT WAS TREATED IN THE EMERGENCY ROOM AND DISCHARGED LATER THAT DAY WITH BG OF 250 MG/DL. AT HOME THE PATIENT'S BG AGAIN ELEVATED AGAIN (500 MG/DL). THIS TIME THE SITE WAS REMOVED AND THE CANNULA WAS FOUND TO BE BENT. AFTER A NEW SITE WAS PLACED, THE PATIENT'S BG REPORTEDLY DECREASED TO 295 MG/DL AFTER THE EVENING MEAL. THE FAMILY MEMBER CONFIRMED THAT THERE WERE NO RELEVANT ALARMS, ALL BOLUSES WERE DELIVERED IN FULL, AND TOTAL DAILY DOSE ADDED UP CORRECTLY. CUSTOMER SUPPORT DETERMINED THAT THERE MAY BE SITE EXHAUSTION GIVEN THE LIMITED AREAS ACCEPTABLE TO THE PATIENT, INCORRECT INFUSION SET INSERTION TECHNIQUES, AND DECREASED INSULIN ACTION DUE TO HEAT EXPOSURE. THE FAMILY MEMBER WAS INSTRUCTED TO REPLACE CARTRIDGES MORE OFTEN WITH INCREASED TEMPERATURE, TO INSERT THE TUBING OF THE INFUSION SET INTO THE NOTCH AFTER COCKING THE INSERTER, AND TO CONTACT THE PATIENT'S HEALTH CARE PROVIDED FOR POSSIBLE NEW INFUSION SITE SELECTION. SHE RESPONDED POSITIVELY TO THE ADVICE AND SUPPORT. THERE HAVE BEEN NO FURTHER REPORTS OF BG EXCURSIONS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY. THIS INFORMATION HAS BEEN FORWARDED TO THE LEGAL MANUFACTURER OF THE PATIENT'S INFUSION SET FOR COMPLAINT ASSESSMENT.

    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 10 YR Hospitalization| R