BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2870177 · Received December 12, 2012

    Report

    Report Number
    2531779-2012-14467
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORIES SHOW THAT BASAL RATES AND PROGRAMMED BOLUSES FOR (B)(6) 2012 CORRECTLY ADD UP AND MATCH THE TOTAL DAILY INSULIN FOR THOSE DATES. THE LAST BASAL DELIVERY OCCURRED ON (B)(6) 2012 AT 10:48 AND THE LAST BOLUS DELIVERY OCCURRED ON (B)(6) 2012 AT 09:32. THE PUMP HISTORIES SHOW THAT THE PUMP WAS SUSPENDED ON (B)(6) 2012 AT 07:40 AND DELIVERIES WERE NOT RESUMED UNTIL (B)(6) 2012 AT 10:10. THE PUMP WAS ALSO SUSPENDED ON (B)(6) 2012 AT 21:12 AND DELIVERIES WERE NOT RESUMED UNTIL (B)(6) 2012 AT 07:39. THERE ARE NO ERRORS OR ALARMS ASSOCIATED WITH THE COMPLAINT OBSERVED IN THE BLACK BOX OR ALARM HISTORY. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT HAD BEEN EXPERIENCING ERRATIC BLOOD GLUCOSE (BG) FOR THE PAST WEEK AND A HALF AND THOUGHT THAT THERE WAS SOMETHING WRONG WITH THE PUMP. THE REPORTER NOTED THAT ON (B)(6) 2012 THE PATIENT EXPERIENCED SEVERE LOW BGS OF 20 MG/DL AND WAS TREATED WITH GLUCOSE TABS/GLUCOSE GEL AND JUICE. THE REPORTER STATED THAT BASAL RATES WERE BEING ADJUSTED AT THE RECOMMENDATION OF THE PATIENT'S HCP AND THE CDE/NURSE PRACTITIONER TO TRY AND TREAT THE ERRATIC BGS. THE BASAL RATES WERE REPORTEDLY LOWERED AT ONE POINT TO AVOID ADDITIONAL LOW BGS, BUT THEN THE PATIENT'S BG WOULD ELEVATE TO "HI" (>600MG/DL). THE REPORTER NOTED THAT THE ERRATIC BGS BEGAN AFTER THE PATIENT HAD A COLD AND WAS ON OVER-THE-COUNTER COLD MEDICATIONS. THE PATIENT REPORTEDLY WAS SLIGHTLY DEHYDRATED AND HAD DECREASED APPETITE/WAS NOT EATING AS MUCH AS USUAL DURING THIS TIME PERIOD AS WELL. A REVIEW OF THE PUMP HISTORIES SHOWED THAT ON (B)(6) 2012, THE BASAL RATES WERE HIGHER THAN ON OTHER DAYS. THE REPORTER COULD NOT PROVIDE A REASON WHY THE BASAL RATES WOULD BE HIGHER ON THOSE DAYS, STATING THAT THERE WERE CHANGES MADE TO THE BASAL RATES DUE TO ERRATIC BGS BUT SHE COULD NOT RECALL WHICH SPECIFIC DAYS THE RATES WERE CHANGED. THE REPORTER NOTED THAT THE PATIENT USUALLY SUSPENDS THE PUMP FOR SHOWERS AND SET CHANGES AND SOMETIMES FORGET TO RECONNECT OR RESUME THE PUMP. TROUBLESHOOTING INDICATED MULTIPLE POSSIBLE CONTRIBUTING FACTORS FOR THE ERRATIC BGS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED SEVERE HYPOGLYCEMIA REQUIRING ASSISTANCE OF ANOTHER PERSON WHILE USING INSULIN PUMP THERAPY. THE REPORTED "HI" BG IS ADDRESSED ON A SEPARATE COMPLAINT.

    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 12 YR Life Threatening