BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2853275 · Received November 30, 2012

    Report

    Report Number
    2531779-2012-14117
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX AND PUMP ALARM HISTORY INDICATED NO ACTIVITY RELATED TO THE COMPLAINT. ALARMS AND WARNINGS INDICATIVE OF TYPICAL PUMP USE WERE OBSERVED. THE PUMP POWERS ON APPROPRIATELY WITH FUNCTIONAL AUDITORY AND VIBRATORY FEATURES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO UNPROGRAMMED BOLUSES OCCURRING. THE KEYPAD BUTTONS WERE TESTED AND THERE WAS NO HYPERSENSITIVITY OBSERVED. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE SUCCESSFULLY PERFORMED AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT SHE WAS RECEIVING AN "EXCEEDS MAX TDD WARNING" ERRONEOUSLY. THE PATIENT STATED HER USER-SET MAXIMUM WAS SET TO 100 UNITS AND HER BASAL WAS SET AT 96 UNITS/DAY AND REPORTED SHE DID NOT GIVE BOLUSES THROUGH PUMP. REVIEW OF PUMP TDD HISTORY REVEALED A TOTAL BASAL OF 103.2 UNITS ON (B)(6) 2012. TDD BASAL FOR (B)(6) 2012 SHOWED 95.2 UNITS. THE PATIENT CONFIRMED THAT THE PUMP'S BASALS WERE SET AS DESIRED OF 0 UNITS FROM MIDNIGHT TILL 1 AM AND 4 U/HR FROM 1 AM TILL MIDNIGHT. AT THE TIME OF TROUBLESHOOTING, REVIEW OF BOLUS HISTORY REVEALED MULTIPLE BOLUSES OF 0.00 U. THE PATIENT INFORMED CUSTOMER SUPPORT THAT SHE DID NOT PROGRAM ANY OF THE BOLUSES OF 0.00 U AND CONFIRMED THERE WERE NO TACTILE CHANGES TO KEYPAD. THESE COMPLAINTS ARE BEING REPORTED BECAUSE THE ALLEGED HISTORY/SETTING ISSUE WITH THE PUMP 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 69 YR