BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3067721 · Received April 19, 2013

    Report

    Report Number
    2531779-2013-04595
    Event Type
    Injury
    Date Received
    April 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    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

    PLEASE OMIT THE FOLLOWING INFORMATION FROM THE PREVIOUS REPORT: NO CONCLUSIONS CAN BE MADE AT THIS TIME. AND REPLACE WITH THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (PRIMING WHILE ATTACHED).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2016 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BLACKBOX BEGINS ON (B)(6) 2016. THE BLACK BOX DATA/HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. THE AVAILABLE BB DATA SHOWS NO VALID LOSS OF PRIME EVENTS. ALL LOSS OF PRIME OBSERVED IN BB ARE RELATED TO PUMP NOT PRIMED AFTER REWIND. A 24HR DURATION TEST WAS SUCCESSFULLY COMPLETED WITH NO LOSS OF PRIME WARNINGS BEING DUPLICATED. THE FORCE SENSOR CALIBRATION CHECK SHOWED THE PUMP IS DETECTING THE CORRECT FORCE. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. REMOVED PUMP COVER; FORCE SENSOR PINS SEATED AND SOLDER CONNECTIONS INTACT. NO EVIDENCE OF CONTAMINATION OR CRACKED FORCE SENSOR TRACES. NO EVIDENCE OF INTERNAL MOISTURE WAS FOUND. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. 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. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT HAD TWO EPISODES OF LOW BLOOD GLUCOSE (BG) RESULTING FROM STAYING CONNECTED WHILE PRIMING AFTER LOSS OF PRIME WARNINGS. THE REPORTER STATED THAT THE FIRST EPISODE OCCURRED ON (B)(6) 2013 WHILE IN SCHOOL. THE PATIENT REPORTEDLY WENT TO THE SCHOOL NURSE AND WAS PALE AND SHAKY WITH A BG OF 47MG/DL. THE PATIENT WAS TREATED WITH JUICE AND THE BG RETURNED TO NORMAL AT 120-180MG/DL. THE REPORTER STATED THAT THE SECOND EPISODE WAS ON (B)(6) 2013 WHILE AT SCHOOL. THE PATIENT WENT TO THE SCHOOL NURSE AND WAS PALE AND SLUGGISH WITH E BG OF 22MG/DL. THE NURSE TREATED THE PATIENT WITH JUICE TIMES THREE AND THE BG RETURNED TO NORMAL AT 110MG/DL. TROUBLESHOOTING INDICATED THAT THE PATIENT IS USING COLD INSULIN AND NOT MAINTAINING STRAIGHT ALIGNMENT OF PLUNGER WHEN LOADING CARTRIDGE. AFTER DISCUSSION WITH MOM, SHE BELIEVES LOSS OF PRIME WARNINGS MAY BE DUE TO THE PATIENT FREQUENTLY DROPPING PUMP AND BANGING IT INTO THINGS. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPOGLYCEMIC EVENT THAT RESULTED FROM PRIMING WHILE ATTACHED, USING COLD INSULIN AND IMPROPER TECHNIQUE WHEN LOADING CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170384 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening