BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242857 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11738
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/22/2013 WITH THE FOLLOWING FINDINGS: 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. DURING A VISUAL INSPECTION, A CRACK IN THE PUMP CASE WAS OBSERVED BY THE TOP-RIGHT CORNER OF THE DISPLAY LENS. DURING TESTING, A PUMP CASE LEAK WAS DETECTED. THE PUMP CASE WAS REMOVED AND CORROSION DUE TO MOISTURE WAS FOUND IN THE PUMP INTERIOR. THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED. WHEN REPLACED WITH A TEST DISPLAY, THE SCREEN FUNCTIONED PROPERLY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. CORRECTION: THE BG OF 50 MG/DL WAS INADVERTENTLY NOT SET AS AN ADVERSE EVENT ON THE ORIGINAL SUBMISSION. THE REPORT IS CORRECTED TO REFLECT AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS AND ALLEGED THAT HER PUMP HAS A CLOUDY DISPLAY, IS DIFFICULT TO READ, AND THAT THIS CONTRIBUTED TO HER BLOOD GLUCOSE (BG) READING DROPPING TO 50 MG/DL. SHE DID NOT FEEL RIGHT, WAS SHAKY AND DISORIENTED. AFTER BG DROPPED, SHE DRANK JUICE AND HER WENT UP TO 90 MG/DL. THE PATIENT STATES THAT THE SHE RECENTLY WENT IN A HOT TUB WITH A TORN KEYPAD AND METAL BENEATH BUTTONS EXPOSED. THE MOISTURE ACROSS THE DISPLAY WAS CRAWLING FROM ONE SIDE TO ANOTHER. CUSTOMER SUPPORT (CS) ADVISED HER IF SHE ENTERED THE WATER WITH PUMP AND THERE WAS DAMAGE TO THE KEYPAD AND WATER GOT IN, MOISTURE WOULD EXPLAIN THE CLOUDY DISPLAY. PATIENT REPORTED THAT SHE COULD NOT SEE THE DISPLAY AND SHE FELT UNSAFE USING THE PUMP AFTER HER DROP IN BG. HOWEVER, SHE DIDN'T HAVE AN ALTERNATE DELIVERY PLAN AND SO RECONNECTED PUMP FOR BASAL. CS EXPLAINED THAT IF SHE DOESN'T FEEL SAFE OR CAN'T SEE THE DISPLAY TO PROPERLY PROGRAM THE PUMP, PLEASE REACH OUT TO HER HEALTH CARE PROVIDER (HCP) TO OBTAIN ORDERS FOR ALTERNATE METHOD OF INSULIN DELIVERY. PATIENT STATES THAT SHE WILL SPEAK TO HCP FOR A BACKUP PLAN, IN CASE IT IS NEEDED IN THE FUTURE. THE BG EXCURSION DOES NOT MEET THE CRITERIA FOR AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DISPLAY ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343477 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR