BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2963117 · Received February 15, 2013

    Report

    Report Number
    2531779-2013-01814
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: DURING EVALUATION, THE PUMP'S HISTORY WAS REVIEWED AND SHOWED THE LAST BASAL DELIVERY WAS ON (B)(4) 2012 AT 10:42 AND THE LAST BOLUS WAS ON (B)(4) 2012 AT 23:31. THE BLACK BOX AND ALARM HISTORY WERE REVIEWED. THERE WERE NO ERRORS OR ALARMS RELATED TO THE COMPLAINT RECORDED; ONLY TYPICAL USAGE WAS OBSERVED. THE TOTAL DAILY INSULIN DELIVERIES ADDED UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES; SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. THE PUMP PASSED THE REQUIRED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. THE COMPLAINT WAS UNABLE TO BE DUPLICATED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 (PATIENT'S FATHER) CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THE PATIENT HAD ELEVATED BLOOD GLUCOSE (BG) OF 400 MG/DL WITH THE NON-SPECIFIC SYMPTOM DESCRIBED AS "FEELS LIKE CRAP." THE REPORTER STATED THAT KETONES ARE NOT TESTED. THE REPORTED ELEVATED BG DOES NOT MEET ANIMAS' CRITERIA OF A REPORTABLE ADVERSE EVENT. THE REPORTER STATED THAT THE PATIENT WAS GOING TO RECEIVE AN INSULIN INJECTION TO CORRECT THE ELEVATED BG AND THEN CHANGE THE SITE/SET. THE REPORTER STATED THE PATIENT'S BG HAS BEEN ELEVATED FOR THE PAST SEVERAL WEEKS AND THEY HAD BEEN MAKING ADJUSTMENTS TO THE PATIENT'S PROGRAMMED BASAL RATES. THE REPORTER REFUSED TO PERFORM TROUBLESHOOTING OF THE PUMP WITH ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) STATING THAT THEY HAD BEEN DEALING WITH THIS SINCE THE PATIENT WAS (B)(6). THE REPORTER STATED HE WAS IN A HURRY AND COULD NOT REMAIN ON THE PHONE WITH ACTS AND FURTHER REFUSED TO ALLOW THE PATIENT'S MOTHER TO SPEAK WITH ACTS IN AN ATTEMPT TO COMPLETE TROUBLESHOOTING ON THE PUMP. THE PUMP IS BEING RETURNED AND REPLACED FOR THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGATION OF AN UNSPECIFIED PUMP MALFUNCTION REMAINED UNRESOLVED AS TROUBLESHOOTING OF THE PUMP WAS DECLINED BY THE REPORTER AND THE EXISTENCE OF A PUMP MALFUNCTION COULD NOT BE CONFIRMED NOR DENIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67977 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR