BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2810264 · Received October 31, 2012

    Report

    Report Number
    2531779-2012-12967
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 4, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A REVIEW OF THE BLACK BOX HISTORY REVEALED NO POWER ON RESETS. THERE WERE NO ALARMS FOUND RELATED TO THE COMPLAINT IN THE PUMP ALARM HISTORY. THERE WAS NO DAMAGE FOUND TO THE RETURNED BATTERY CAP OR THE BATTERY COMPARTMENT. THE BATTERY CAP MET ALL SPECIFICATIONS AND SECURED TIGHTLY TO THE PUMP WITH NO VISIBLE YELLOW O-RING. THE REWIND, PRIME AND LOAD STEPS WERE PERFORMED WITH NO ISSUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH RETURNED BATTERY CAP WITH NO POWER ISSUES. A BATTERY CAP FUNCTIONAL TEST WAS PERFORMED AND NO BATTERY CAP CONNECTION DEFECTS WERE NOTED. THERE WAS NO EVIDENCE OF MOISTURE OR DAMAGE FOUND TO THE BATTERY FLEX OR POWER CIRCUIT. THE REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A FADED/DISCOLORED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S MOTHER CONTACTED ANIMAS ALLEGING THAT DURING THE MIDDLE OF THE NIGHT THE SUBJECT PUMP BUZZED AND MADE 3 LOUD BEEPS AND CONTINUED TO DO THAT RANDOMLY DURING THE NIGHT. THE REPORTER DENIED SEEING ANY ALARM AT THE TIME THE PUMP WAS MAKING THE UNUSUAL SOUNDS. AT THE TIME OF THE CALL, THE PATIENT'S MOTHER MENTIONED THAT SHE HAD ALSO NOTICED THE IOB (INSULIN ON BOARD) WAS CLEARED. CUSTOMER SUPPORT INFORMED THE REPORTER THAT THE PUMP MAY HAVE REBOOTED ITSELF. THE PATIENT'S MOTHER STATED THE PATIENT HAD AN ELEVATED BLOOD GLUCOSE (BG) OF 340 MG/DL AT TIME OF THE ISSUE. THE REPORTER DENIED THAT THE PATIENT DEVELOPED ANY SYMPTOMS WITH THE HIGH BG. THE PATIENT'S MOTHER CLAIMED SHE WAS ABLE TO CORRECT FOR THE HIGH BG SUCCESSFULLY. ANIMAS CUSTOMER SUPPORT NOTED THAT THE REPORTER HAD CALLED IN A COUPLE OF DAYS PRIOR TO REPORT THAT THE RUBBER OVER THE OK UP TO THE UP ARROW BUTTON WAS PEELING UP. AT THE TIME OF THE CALL, THE PATIENT'S MOTHER DENIED ANY EVIDENCE OF MOISTURE INGRESS WITHIN THE PUMP. THE PATIENT'S REPORTED BG READING DOES NOT MEET ANIMAS' CRITERIA OF A SERIOUS INJURY; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    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