BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3021510 · Received March 26, 2013

    Report

    Report Number
    2531779-2013-03083
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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. 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

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. REMAINING INSULIN WAS CALCULATED ACCURATELY. A CARTRIDGE WITH 100 UNITS WAS CORRECTLY LOADED INTO THE PUMP. UNABLE TO DUPLICATE REPORTED INACCURATE REMAINING INSULIN. BLACK BOX FOR 2/26: 179 UNITS AT 10:04AM; A LOSS OF PRIME OCCURS AT THEN FOLLOWING A REWIND, LOAD WITH A PRIME OF 10.3 UNITS 116 UNITS REMAIN AT 10:50AM THIS LEAVES APPROXIMATELY 53 UNITS UNACCOUNTED; 114 UNITS AT 12:55PM; A LOSS OF PRIME OCCURS AT 12:58PM THEN FOLLOWING A REWIND, LOAD WITH A PRIME OF 8.6 UNITS 88 UNITS REMAIN AT 1:04PM THIS LEAVES APPROXIMATELY 17 UNITS UNACCOUNTED. 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) 2013, THE REPORTER, THE PATIENT'S MOTHER, CONTACTED ANIMAS AND ALLEGED THAT 89.1 UNITS OF INSULIN ARE UNACCOUNTED FOR SINCE A CARTRIDGE CHANGE THIS MORNING. MOM FILLED CARTRIDGE THIS AM. TOTAL WAS 179 UNITS AFTER COMPLETED TOTAL REWIND LOAD AND PRIME OF COMPLETE SET CHANGE. MOM (B)(6) IS REPORTING PROPER PREP AND A PRIME VOLUME AT 656 AM OF 9.5 UNITS FOR A 23 INCH 9MM INSET. CARTRIDGE CURRENTLY WITH 43 UNITS LEFT IN PUMP AT THIS TIME. SHE REMOVED CARTRIDGE AND SAYS YES INSULIN ON SECOND LINE THAT WOULD BE THE 40 UNIT MARK. NO LEAKAGE IS REPORTED. TDD WAS 17.5 UNITS TODAY. PRIME HISTORY TODAY HAS TOTAL OF 29.4 UNITS FOR OVERALL DELIVERY OF 46.9 UNITS USED TODAY. BUT ONLY 43 UNITS IN THE PUMP, AND HAD 179 UNITS TODAY AT 700 AM AFTER CARTRIDGE CHANGE, LEAVING 89.1 UNITS UNACCOUNTED FOR MOM REPORTING NO BOLUS TODAY, NO ALARMS. LAST ALARM WAS LOW CARTRIDGE ON (B)(6) 2013. ONLY WARNING TODAY IS THREE LOSS OF PRIMES, GREATER THAN 2 HOURS APART. PUMP WAS DISCONNECTED FROM PATIENT WHEN PRIMING . TIME AND DATE IS CORRECT IN THE PUMP. BG AT TIME OF CALL WAS 51MG/DL WITH MODERATE LIGHT HEAD AND SHAKY. TREATED WITH 27 GRAM CARBOHYDRATE PER MOM OF SODA AND HAVING HER EAT. HER BG AT END OF CALL BEFORE EATING IS 71MG/DL WITH A 80MG/DL TARGET. MOM REPORTS ISF IS 40MG/DL TO 50MG/DL AND CONCERN ABOUT MISSING INSULIN OF 89 UNITS AND POINT DROP NOT INCLUDING FOOD OF OVER 3000 POINTS. MOM SAYS SHE KNOWS WHAT TO DO AND WILL ASSESS PATIENT ALL THRU THE NIGHT TONIGHT. CTS WAS UNABLE TO DETERMINE CAUSE OF MISSING INSULIN AND ADVISED PATIENT TO GO ON ALTERNATE DELIVERY METHOD OF INSULIN. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PUMP IS INACCURATELY DELIVERING INSULIN. THE BG EXCURSION DOES NOT MEET THE CRITERIA OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123129 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR