BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2771201 · Received October 3, 2012

    Report

    Report Number
    2531779-2012-11750
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 7, 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

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) 2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE FADED AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S MOTHER/REPORTER CLAIMED THE PATIENT HAD UNEXPLAINED ELEVATED BLOOD GLUCOSE READING INTO THE 400'S MG/DL FOR THE PAST 6-7 WEEKS. AT THE TIME OF CONCERN, THE PATIENT WAS FEELING IRRITABLE AND THIRSTY. ON (B)(6) 2012, THE PATIENT TOOK BOLUS INSULIN WITH THE SUBJECT PUMP THROUGHOUT THE DAY BUT HIS BLOOD GLUCOSE WAS STILL IN THE MID 400 MG/DL AT 5:00 PM. BY 8:20 PM, THE PATIENT SWITCHED TO A LOANER PUMP. HIS BLOOD GLUCOSE RESOLVED TO 112 MG/DL. ON THE MORNING OF (B)(6) 2012, THE PATIENT AWOKE WITH A BLOOD GLUCOSE READING OF 103 MG/DL. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE ASSESSED THE PATIENT'S ALLEGED BLOOD GLUCOSE EXCURSION BY EVALUATING THE ANIMAS PUMP. THE ADVANCE FEATURES AND THE BASAL SEGMENT ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT'S USAGE AT THE TIME OF THE EVENT. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THE PUMP DELIVERED INSULIN ACCORDINGLY AND NO INACCURATE DELIVERY ISSUE WAS FOUND. THERE WAS NO PRODUCT MISUSED. THERE WAS NO EVIDENCE OF A PUMP MALFUNCTION ASSOCIATED WITH THE ALLEGED EVENT. THE SUBJECT PUMP WAS REPLACED AND REQUESTED BACK TO BE SENT BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE UNEXPLAINED ELEVATED BLOOD GLUCOSE WHILE ON INSULIN PUMP THERAPY. IT IS NOT CLEAR WHETHER USE ERROR, OR INTENTIONAL MISUSE ATTRIBUTED TO THE REPORTED INCIDENT. THE PATIENT'S CONDITION DID NOT MEET ANIMAS CRITERIA OF A SERIOUS INJURY AT THE TIME OF CONCERN.

    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 8 YR