BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2802309 · Received October 24, 2012

    Report

    Report Number
    2531779-2012-12671
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 12/20/2012 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK HISTORY REVEALED THAT THE DATES IN TOTAL DAILY DOSE HISTORY CHANGED FROM (B)(6) 2012 TO (B)(6) /2012. NO DATA WAS FOUND IN THE BLACK BOX FROM THE TIME OF THE REPORTED EVENT DUE TO CONTINUED USE. INVESTIGATION WAS UNABLE TO BE COMPLETED DUE TO UNRESPONSIVE KEYPAD BUTTONS.

    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

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED ANIMAS (ANM) ALLEGING THAT THE PUMP HAD AN UNSPECIFIED DATE/TIME ISSUE. THE PATIENT ALSO ALLEGED THAT THE DATE/TIME ISSUE CONTRIBUTED TO HAVING HIGH BLOOD GLUCOSE (BG) LEVELS. IN ONE INSTANCE, THE PATIENT CLAIMED THAT HE DEVELOPED A BG LEVEL OF "500 MG/DL". HE MENTIONED THAT PARAMEDICS RESPONDED. HOWEVER, IT IS UNKNOWN IF WHAT TREATMENT, IF ANY, THE PATIENT RECEIVED FROM THE PARAMEDICS. HE DENIED BEING HOSPITALIZED. MULTIPLE ATTEMPTS BY ANM TO CONTACT THE PATIENT FOR FOLLOW-UP INFORMATION HAVE BEEN UNSUCCESSFUL. THE PUMP WAS REPLACED DUE TO AN ALLEGED KEYPAD ISSUE THAT WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PATIENT DID NOT ALLEGE ANY HARM/INJURY BECAUSE OF THE ALLEGED KEYPAD ISSUE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED AN ELEVATED BG LEVEL AND RECEIVED MEDICAL ATTENTION AS A RESULT OF AN UNSPECIFIED DATE/TIME ISSUE WITH THE PUMP. HOWEVER, AT THIS TIME, IT IS UNCLEAR IF THE PUMP, USE-ERROR, AND/OR DIABETES MANAGEMENT FACTORS CONTRIBUTED TO THE PATIENT'S INJURY.

    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 51 YR Life Threatening