BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2249702 · Received September 15, 2011

    Report

    Report Number
    2531779-2011-06836
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP AND CARTRIDGE HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/12/2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY DID NOT INDICATE THAT THE PUMP DID NOT RECOGNIZE THE CARTRIDGE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO INSULIN DELIVERY ISSUES OCCURRING. AN EZPRIME OPERATION WAS PERFORMED WITH NO ISSUES OCCURRING. EVALUATION REVEALED THAT THE FORCE SENSOR ASSEMBLY WAS PHYSICALLY DAMAGED. 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. THE CARTRIDGE WAS RETURNED WITH THE PUMP FOR INVESTIGATION. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. FORCE, FILL, AND LEAK TESTS WERE PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION. CARTRIDGE INFORMATION: BRAND NAME: ANIMAS INSULIN CARTRIDGE. COMMON DEVICE NAME: INSULIN INFUSION PUMP CARTRIDGE. MODEL #: ANM (B)(4) CART. LOT #: B201670, CATALOG #: 100-124-01. PMA/510(K) #: K032257. LABELED FOR SINGLE USE? YES. CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP HAS DISPENSED INSULIN DURING THE LOAD STEP ON THREE SEPARATE OCCASIONS OVER THE PAST TWO WEEKS. HE NOTED THAT THE MOST RECENT OCCURRENCE WAS (B)(6) 2011. HE STATED THAT THE PUMP DID NOT EMIT A "NO CARTRIDGE DETECTED" WARNING DURING ANY OF THE INCIDENTS.

    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 36 YR