BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3232124 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11107
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER REMOTE 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 METER AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 11/14/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/04/2013 WITH THE FOLLOWING FINDINGS: THE PUMP WAS NOT RETURNED WITH THE METER FOR TESTING. THE METER WAS POWERED ON AND PAIRED SUCCESSFULLY WITH A TEST PUMP. A 3.35 UNIT COMBO BOLUS WAS GIVEN SUCCESSFULLY AND COMPLETELY. THE COMPLAINT COULD NOT BE DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS ALLEGING THAT A BOLUS THAT WAS DELIVERED VIA THE METER REMOTE WAS NOT SHOWING IN THE PUMP HISTORY. THE REPORTER STATED THAT A COMBO BOLUS FOR 3.5UNITS WAS PROGRAMMED VIA THE METER REMOTE AT 12:23PM ON (B)(6) 2013 TO COVER THE PATIENT¿S LUNCH. UPON REVIEW OF THE PUMP HISTORY, THIS BOLUS DID NOT RECORD IN THE PUMP HISTORY. CUSTOMER TECHNICAL SUPPORT CONFIRMED WITH THE REPORTER THAT THE PUMP AND METER WERE PAIRED. A REVIEW OF THE PUMP HISTORY SHOWED THE MOST RECENT BOLUS AT 10:02AM THAT SAME DAY. THREE TEST BOLUSES WERE PERFORMED VIA THE METER REMOTE DURING TROUBLESHOOTING, AND THE THREE BOLUSES APPROPRIATELY RECORDED IN THE PUMP HISTORY. THERE WERE NO ALARMS ASSOCIATED WITH THE COMPLAINT OBSERVED IN THE PUMP¿S ALARM HISTORY. THE REPORTER CONFIRMED THAT THE TIME AND DATE ON THE PUMP WERE CORRECT. THE REPORTER NOTED THAT THE METER REMOTE RECORDS SHOWED THE AMOUNT OF CARBOHYDRATES THAT HAD BEEN ENTERED FOR THE PATIENT¿S LUNCH, BUT DID NOT SHOW A BOLUS DELIVERED. THE REPORTER STATED SHE HAS LOST CONFIDENCE IN THE METER REMOTE AND THE METER REMOTE WAS REPLACED. THE REPORTER NOTED THAT THE PATIENT¿S BLOOD GLUCOSE (BG) WAS 217MG/DL WITH NO SIGNS OR SYMPTOMS AT THE TIME OF THE CALL TO ANIMAS. THE PATIENT WAS REPORTEDLY GIVEN A CORRECTION BOLUS TO COVER ELEVATED BG. THE REPORTED BG EXCURSION DOES NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE METER REMOTE DID NOT DELIVER A PROGRAMMED BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331495 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR