BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3062497 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04378
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION - (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: REBOOTS FOUND IN BLACK BOX. NO DAMAGE FOUND TO BATTERY CAP OR BATTERY COMPARTMENT. BATTERY CAP WAS ABLE TO ATTACH SECURELY TO PUMP. PUMP POWERS ON NORMAL WITH NO ALARMS. PUMP WAS EXERCISED FOR 24 HRS WITH NO POWER ISSUES OR ALARMS OCCURRING. BATTERY CAP CONTACT HEIGHT AND WIDTH WITHIN SPECIFICATION. PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO POWER CIRCUIT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP EMITTED A REPLACE BATTERY ALARM, THE PUMP WAS REBOOTED WITH THE SAME BATTERY AND THE REWIND LOAD AND PRIME WERE PERFORMED BUT THEN THE PUMP REPORTEDLY TURNED OFF. THE REPORTER STATED THAT THE BATTERY WAS NOT REPLACED BECAUSE THE PUMP BATTERY INDICATOR SHOWED FULL POWER EARLIER IN THE DAY. THE REPORTER INDICATED THAT THE PUMP WAS REBOOTED THREE TIMES AND FINALLY THE PUMP POWERED ON NORMALLY AND WAS FINE AFTERWARDS. THE REPORTER CONFIRMED THAT THERE WAS NO KNOWN DAMAGE TO THE PUMP OR BATTERY CAP. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164244 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR