BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4221928 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31301
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/30/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX SHOWED THAT OCCLUSION ALARMS HAD OCCURRED ON 10/29/2014 AT 16:42 AND 17:00 ASSOCIATED WITH HIGH FORCE READINGS. THE PUMP DELIVERIES WERE RESUMED ON (B)(6) 2014 AT 13:14. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT OCCLUSION ALARMS OCCURRING. THE FORCE SENSOR CALIBRATION CHECK SHOWED THAT THE PUMP WAS DETECTING FORCE WITHIN REQUIRED SPECIFICATIONS. A FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED BETWEEN THE BUMPER PAD AND THE PUMP COVER. THE RETURNED BATTERY CAP WAS ABLE TO SECURE TO THE PUMP AND WAS USED TO COMPLETE TESTING. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A BLOOD GLUCOSE AS HIGH AS 30 MMOL/L ASSOCIATED WITH OCCLUSION ALARMS ON THE PUMP. THE REPORTER DID NOT PROVIDE A SPECIFIC DATE OF THE HIGH BLOOD GLUCOSE. THE REPORTER INDICATED THAT CHANGING THE CARTRIDGE AND TUBING DID NOT RESOLVE THE OCCLUSION ISSUE. THE REPORTER CONFIRMED THAT THE CARTRIDGES AND INFUSION SETS WERE BEING USED PER THE INSTRUCTIONS FOR USE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO A PUMP OCCLUSION ALARM ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701881 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening