BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3113376 · Received May 15, 2013

    Report

    Report Number
    2531779-2013-06436
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: BLACK BOX REVIEW SHOWS AN EMPTY CARTRIDGE WARNING ON (B)(4) 2013 AT 01:35 AM FOLLOWED BY AN ¿EZ-PRIME¿ OPERATION, NO CARTRIDGE CHANGE OR ANY PRIME OPERATION WAS PERFORMED BETWEEN (B)(4) 2013. SEVERAL SUSPEND WERE OBSERVED IN-BETWEEN. PUMP POWERS ¿ON¿ AND DISPLAYS ¿VERIFY¿ SCREEN. PUMP PASSED ¿EZ-PRIME¿ OPERATIONS AND PAIRS WITH ATTEST METER SUCCESSFULLY. A 24 HOUR DURATION TEST WAS PERFORMED ON THE PUMP. NO ALARMS OR DELIVERY INTERRUPTION OCCURRED DURING THE DURATION TEST. MULTIPLE ¿EZ-PRIME¿ OPERATIONS WERE PERFORMED DURING THE INVESTIGATION; THE UNIT RECORDED PRIME INFO ON THE CORRECT TIME AND ORDER. PUMP WAS OPENED AND INSPECTED, NO MOISTURE INGRESS WAS FOUND TO THE PCB, NO DEFECT WAS FOUND TO THE FORCE SENSOR CIRCUIT OR TO THE POWER CIRCUIT. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 STATING THE PATIENT HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) FOR THE PAST WEEK, ELEVATING TO 400 MG/DL WITHOUT REPORTED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. THE REPORTED ELEVATED BG DOES NOT MEET ANIMAS CRITERIA FOR A REPORTABLE ADVERSE EVENT. THE REPORTER STATED THAT THE PATIENT IS ONLY ABLE TO LOWER HER BG TO WITHIN TARGET RANGE BY GIVING SUPPLEMENTAL INSULIN VIA MANUAL INJECTION. ON TROUBLESHOOTING, THERE WERE NO RELATED ALARMS RECORDING IN THE ALARM HISTORY. THE REPORTER VERIFIED THAT THE PROGRAMMED SETTINGS ARE AS INTENDED. THE REPORTER AND THE PATIENT REPORTED THAT THE PATIENT PERFORMED A SITE/SET CHANGE ON (B)(6) 2013; HOWEVER, THERE IS NO RECORDED INFORMATION IN THE PUMP HISTORY TO SUPPORT THIS CLAIM. THE PUMP HISTORY REVEALED LOW PRIME VOLUMES RECORDED FROM (B)(6) 2013. THE REPORTER VERIFIED THE CARTRIDGE PREPARATION WAS APPROPRIATE AND THE PUMP IS PRIMED UNTIL 5 DROPS OF INSULIN ARE SEEN COMING FROM THE TUBING. THE REPORTER VERIFIED THAT THE PRIMING IS DONE BY THE PUMP ALONE WITH NO MANUAL PRIMING PERFORMED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED LOAD STEP MALFUNCTION AND MISSING INFORMATION IN THE PUMP HISTORY REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215748 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR