BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3122560 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06817
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP¿S BLACK BOX HISTORY WAS REVIEWED AND SHOWED THE LAST BASAL DELIVERY AND THE LAST BOLUS WERE RECORDED ON (B)(6) 2013. THERE WERE NO ALARMS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY; ONLY TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED. THE TOTAL DAILY DOSAGE¿S ADDED UP CORRECTLY TO REFLECT THE USER¿S PROGRAMMED BASAL RATES. THE PUMP SUCCESSFULLY COMPLETED THE REQUIRED (B)(4) FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THE COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION AND THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT WHILE ON AN ALTERNATE DELIVERY METHOD, WAITING FOR A REPLACEMENT PUMP TO ARRIVE, SHE FAINTED AT WORK , WAS TAKEN TO URGENT CARE AND TRANSPORTED TO THE HOSPITAL. SHE HAD HYPOGLYCEMIC EXCURSIONS, THE LOWEST BG WAS 29 MG/DL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPOGLYCEMIA AFTER BEING TOLD BY CUSTOMER SUPPORT (CS) TO DISCONTINUE USING THEIR PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223759 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization