BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2430592 · Received January 27, 2012

    Report

    Report Number
    2531779-2012-00721
    Event Type
    Malfunction
    Date Received
    January 27, 2012
    Report Date
    December 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    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. RECALL #2531779-03/24/2010-003-R.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/11/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/30/2015 WITH THE FOLLOWING FINDINGS: THERE WAS NO EVIDENCE OF A RELATED ALARM OBSERVED IN THE PUMP'S BLACK BOX. A LOAD STEP MALFUNCTION WAS NOT DUPLICATED DURING INVESTIGATION. THE PUMP'S FORCE SENSOR PASSED A CALIBRATION CHECK. THE BATTERY COMPARTMENT WAS CRACKED FROM THE TOP TRAVELING TO THE BUMPER. THE THREADS ON THE BATTERY CAP WERE STRIPPED AND UNABLE TO SECURE.

    Description of Event or Problem · 1

    THE PATIENT'S SPOUSE CONTACTED ANIMAS ON (B)(6) 2011 TO REPORT A LOSS OF PRIME WARNING. AT THE TIME OF TROUBLESHOOTING, ANIMAS CUSTOMER SUPPORT ATTEMPTED TO WALK THE REPORTER THROUGH PRIMING THE PUMP; HOWEVER, DURING THE LOAD STEP RECEIVED A NO CARTRIDGE DETECTED ALARM. AT THE TIME OF TROUBLESHOOTING, THE PATIENT'S SPOUSE CONFIRMED THE PATIENT WAS DISCONNECTED FROM THE PUMP. SHE INFORMED CUSTOMER SUPPORT THAT THE PATIENT HAD PUT A FULL 2.0ML CARTRIDGE IN THE COMPARTMENT AND SECURED THE CAP. AFTER RECEIVING THE NO CARTRIDGE DETECTED ALARM THE REPORTER REMOVED THE CARTRIDGE FROM THE PUMP AND CONFIRMED THERE WAS NO INSULIN IN THE CARTRIDGE. THE REPORTER DID NOT KNOW WHERE THE INSULIN WENT. SHE CONFIRMED THE PATIENT WAS DISCONNECTED AND CONFIRMED THE CAP WAS SECURED PRIOR TO INITIATING THE LOAD STEP. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE, THE ALLEGED ISSUE REMAINED UNRESOLVED.

    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 64 YR