BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2946263 · Received February 6, 2013

    Report

    Report Number
    2531779-2013-01534
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    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) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED REBOOTS. NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT OR BATTERY CAP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR POWER ISSUES OCCURRING. THE PUMP COVER WAS REMOVED AND NO EVIDENCE OF MOISTURE WAS FOUND IN THE POWER CIRCUIT OR BATTERY FLEX. NO INTERMITTENT CONNECTIONS WERE FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING THAT THE PUMP POWERED OFF WITH NO WARNING. THE PATIENT STATED THAT THE PUMP EMITTED A "LOW BATTERY" WARNING ON (B)(4) 2013 AND THEN HE CHANGED OUT THE BATTERY AFTER HE RECEIVED THE WARNING. THE PUMP REPORTEDLY DID NOT EMIT ANY WARNING ON THE DAY IT POWERED DOWN. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP HISTORY AND ONLY ONE "LOW BATTERY" ALARM ON (B)(4) /2013 HAD RECORDED AND NO OTHER ALARMS WERE NOTED. THE PATIENT DENIED DAMAGE TO THE BATTERY COMPARTMENT OR BATTERY CAP. THERE WAS REPORTEDLY NO MOISTURE OR CORROSION FOUND INSIDE THE PUMP. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED POWER ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50235 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR