BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3061582 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04353
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMITTED: (B)(4) 2013. DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX REVEALED LOSS OF PRIME WARNINGS ASSOCIATED WITH OCCLUSION ALARMS. ON INVESTIGATION, THE PUMP POWERED ON WITH APPROPRIATE AUDITORY AND VIBRATORY FUNCTIONALITY. THE EZ-PRIME FUNCTION WAS INITIATED AND WAS PERFORMED WITHOUT DIFFICULTY. THE FORCE SENSOR WAS NOTED TO BE CALIBRATED WITHIN SPECIFICATIONS. THE OCCLUSION ALARM WAS CONFIRMED AND THE PUMP WENT TO A "NO PRIME WARNING" AFTERWARD. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO LOSS OF PRIME DUPLICATED. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, WHICH HAS NOT EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP. ALSO UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED A PUNCTURED BOLUS BUTTON. A DAMAGED BOLUS BUTTON WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTON, WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE DAMAGED BOLUS BUTTON SHOULD BE CLEARLY VISIBLE AND PROHIBIT THE USE OF THE KEYPAD BUTTONS. USERS MAY EXPECT BUTTON DAMAGE DURING NORMAL WEAR AND THE OWNER¿S BOOKLET INSTRUCTS THE USER TO CONTACT CUSTOMER SERVICE IF THE USER SUSPECTS THE PUMP MAY BE DAMAGED. ALSO UNRELATED TO THE COMPLAINT, THE DISPLAY WAS NOTED TO BE REDDISH IN COLOR AND DIFFICULT TO READ. 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.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013: THE DISPLAY HAD A REDDISH TINT AND THE INFORMATION WAS DIFFICULT TO READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162962 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR