BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3080337 · Received April 26, 2013

    Report

    Report Number
    2531779-2013-05356
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. A (B)(4) FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. THERE WERE NO ALARMS OR ERRORS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY, ONLY TYPICAL USAGE WAS OBSERVED. .THE DAILY INSULIN DELIVERY TOTALS WERE REVIEWED AND CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING THAT SHE EXPERIENCED LOW BLOOD GLUCOSE (BG) OVER THE PAST SEVERAL WEEKS, GOING DOWN TO AS LOW AS 38 MG/DL WITH SYMPTOMS OF AGITATION, DIAPHORESIS AND HEART PALPITATIONS. THE PATIENT STATED SHE HAS NOT NEEDED MEDICAL INTERVENTION FOR THE LOW BG AND WAS ABLE TO SUCCESSFULLY SELF-TREAT FOR THE LOW BGS WITH ORAL CARBOHYDRATES. THE PATIENT REPORTED THAT SHE HAS BEEN IN CONTACT WITH HER HEALTHCARE PROVIDER DURING THIS TIME. THE PATIENT STATED THAT THE DIABETES EDUCATOR BELIEVES THERE IS A DELIVERY ISSUE WITH THE PUMP AND THAT PROGRAMMING ADJUSTMENTS HAVE NOT ALLEVIATED THE LOW BG ISSUE FOR THE PATIENT. THE PATIENT DENIED ILLNESS, MEDICATIONS, ALCOHOL INVOLVEMENT OR CHANGE IN ACTIVITY. THE PATIENT STATED THAT AFTER CONSUMING 20 GRAMS OF CARBOHYDRATES, SHE DELIVERED 3.8 UNITS OF INSULIN VIA THE PUMP AND HER BG CONTINUALLY WENT DOWN FROM 155 MG/DL TO 38 MG/DL OVER APPROXIMATELY 90 MINUTES. AT THE TIME OF THE CALL TO ANIMAS, THE PATIENT REPORTED HER BG WAS 200 MG/DL. THE PATIENT STATED THAT AT THAT TIME, SHE NO LONGER TRUSTED THE PUMP. TROUBLESHOOTING BY ANIMAS CUSTOMER TECHNICAL SUPPORT FAILED TO REVEAL ANY MALFUNCTION IN THE OPERATION OF THE PUMP OR SETTINGS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED LOW BG WHILE ON INSULIN PUMP THERAPY, WHICH WAS NOT RESOLVED WITH SETTINGS CHANGES OR TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181217 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening