BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2841897 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13828
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE ARE NO ERRORS OR ALARMS RELATED TO THE COMPLAINT OBSERVED IN THE BLACK BOX OR ALARM HISTORY. A REVIEW OF THE PUMP HISTORY SHOWS THAT THE LAST BOLUS OCCURRED ON (B)(6) 2012 AT 21:47 AND THE LAST BASAL DELIVERY WAS ON (B)(6) 2012 AT 22:59. A MANUAL DATE AND TIME CHANGE WAS OBSERVED IN THE BLACK BOX, FROM (B)(4) 2012 00:59 TO (B)(4) 2012 23:58. THEN ON (B)(4) 2012 AT 13:4 THE DATE WAS CHANGED BACK TO (B)(4) 2012; THE TIME WAS NOT ADJUSTED. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. UNRELATED TO THE COMPLAINT, THERE WAS VISIBLE MOISTURE OBSERVED IN THE DISPLAY LENS. A LEAK TEST REVEALED A LEAK NEAR THE UPPER RIGHT CORNER OF THE PUMP CASE BETWEEN THE DISPLAY LENS AND THE CASE SEAL.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 STATING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) AS HIGH AS 32.5 MMOL/L WITH INCREASED THIRST AND URINATION. THE REPORTER STATED THAT EARLIER IN THE NIGHT THE PATIENT'S BG WAS 6.5 MMOL/L; THE PATIENT REPORTEDLY BOLUSED AND ATE DINNER AND THE BG ELEVATED TO 30 MMOL/L. THE REPORTER STATED THAT THE PATIENT WAS GIVEN A CORRECTION AND BG DECREASED TO 28.5 MMOL/L BUT BY THE TIME OF THE CALL WITH ANIMAS THE BG HAD ELEVATED TO 32.5 MMOL/L. THE REPORTER STATED THAT THE PATIENT'S BG WAS IN CONTROL UP UNTIL THIS EVENT. THE REPORTER STATED THAT THE SITE WAS RECENTLY CHANGED AND APPEARS TO BE WORKING AT THIS TIME, NO REDNESS, NO SORENESS, NO LEAKS, AND NO AIR BUBBLES. THE PUMP WAS REVIEWED AND CONFIRMED THAT THE PUMP BOLUS HISTORY CORRECTLY REFLECTED THE BOLUSES REPORTED; THE PUMP BASAL DELIVERY SHOWED THAT THE PUMP WAS DELIVERY APPROPRIATELY. THE REPORTER CONFIRMED THAT THE PUMP PRIME HISTORY APPEARED APPROPRIATE. CUSTOMER SUPPORT ADVISED THE REPORTER THAT THERE WAS NO INDICATION OF A MECHANICAL ISSUE WITH THE PUMP. THIS REPORT IS MADE BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA OF UNKNOWN ORIGIN WHILE USING THE INSULIN PUMP.

    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 5 YR Life Threatening