BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2904933 · Received January 9, 2013

    Report

    Report Number
    2531779-2013-00451
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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: A REVIEW OF THE PUMP HISTORY AND THE BLACK BOX SHOWS A +70% TEMPORARY BASAL PROGRAM WAS SET AT 3:30PM ON (B)(4) 2012 RESULTING IN A 4.462UNIT/HOUR BASAL RATE. AT 5:30PM, THE BASAL RATE CHANGED TO A 3.20UNIT BASAL RATE, AND THIS IN COMBINATION WITH THE EXISTING TEMP BASAL RATE TRIGGERED THE "EXCEEDS MAX BASAL" ALERT THAT WAS OBSERVED IN THE BLACK BOX FOR (B)(4) 2012. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO DELIVERY ISSUES AND NO CHANGES IN THE BASAL PROGRAM. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE SUCCESSFULLY PERFORMED AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD BUTTONS WERE TESTED AND NO HYPERSENSITIVITY WAS OBSERVED. THE COMPLAINT COULD NOT BE DUPLICATED DURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    ON (B)(4) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT THAT HE RECEIVED AN UNEXPLAINED MAX BASAL ALARM A COUPLE OF TIMES EARLIER THAT MORNING. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. AT THE TIME OF THE CALL, THE PATIENT INFORMED CUSTOMER SUPPORT THAT THE PUMP WAS SET TO ALARM WHEN HE EXCEEDED 5 U/HOUR OF BASAL DELIVERY. REVIEW OF PUMP SETTINGS REVEALED THAT THE PUMP WAS AHEAD BY 1 HOUR. THE PATIENT CONFIRMED HE DID NOT CHANGE TIME ON THE PUMP FOR DAYLIGHT SAVINGS. THE PATIENT CHANGED THE PUMP'S TIME AT THE TIME OF THE CALL. REVIEW OF BASAL RATE REVEALED BASAL RECORDS AT 8:51AM 3.275U, AT 5:30AM 0.0U, AT 3:30AM 4.46U AND AT 1:18AM 0.85U. CUSTOMER SUPPORT NOTED THAT THE PATIENT CLAIMED THERE WAS NO EXPLANATION FOR THE BASAL RATE OF 4.46U OR THE 0.0U IN THE MIDDLE OF THE NIGHTS. THE PATIENT DENIED MAKING ANY CHANGES TO HIS SETTINGS OR CHANGING OUT HIS SITE AT THE RECORDED TIMES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WITH INCORRECT BASAL RECORDS IN BASAL HISTORY REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11202 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR