BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3000254 · Received March 12, 2013

    Report

    Report Number
    2531779-2013-02627
    Event Type
    Injury
    Date Received
    March 12, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    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: THE BASAL HISTORY SHOWS ON (B)(6) 2013 17:35 A 0.00U BASAL RATE WAS PROGRAMMED UNTIL (B)(6) 2013 17:35. THERE WERE NO ALARMS OR ERRORS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY, ONLY TYPICAL USAGE WAS OBSERVED. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. A FORCE SENSOR CALIBRATION CHECK REVEALED THE FORCE SENSOR WAS OUT OF CALIBRATION. THE FORCE SENSOR RESISTANCE WAS WITHIN SPECIFICATIONS. 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 REPORTER CONTACTED ANIMAS ON (B)(4) 2013 REPORTING THAT THE PATIENT HAS HIGH BLOOD GLUCOSE (BG) ON AND OFF FOR THE PAST FEW WEEKS AND THEN LAST 24 HOURS HE HAD BEEN CONSISTENTLY HIGH. THE REPORT STATED THAT THE PATIENT'S BG WAS 180MG/DL, THE PATIENT HAD PIZZA FOR DINNER AND GAVE A EZCARB CORRECTION. THE BG AT BEDTIME WAS 400MG/DL THE SITE WAS CHANGED, BOLUSED WITH THE PUMP AND WENT TO BED. AT 3AM THE PATIENT'S BG WAS 500MG/DL WITH NAUSEA, INSET WAS CHANGED AND TOOK A SHOT WITH A SYRINGE. HIS BG AT 7AM WAS 180MG/DL WITH NAUSEA. THE PATIENT'S STAYED AT 400MG/DL THROUGHOUT THE DAY AND THE PATIENT CHANGES SET AGAIN AND TOOK A SHOT WITH SYRINGE. THE REPORTER DENIED ILLNESS, WEIGHT LOSS, STRESS, CHANGE IN PHYSICAL ACTIVITY, CHANGE IN MEDICATION, SITE PROBLEMS. THE REPORTER REQUESTED THAT THE PUMP BE REPLACED AND STATED THAT THE HEALTHCARE PROFESSIONAL WAS PUZZLED AS TO WHY THE PATIENT HAD BEEN HIGH SO OFTEN. THE REPORTER CONFIRMED THAT THE BASAL SETTINGS ARE CORRECT. THE REPORTER (ALSO THE FATHER) STATED THAT HE MADE MINOR BASAL RATE ADJUSTMENTS TWO MONTHS AGO. CUSTOMER SUPPORT DETERMINED THERE IS NO MALFUNCTION WITH THE PUMP. ALTHOUGH NO SPECIFIC EVIDENCE OF PUMP MALFUNCTION, DEFECT, OR MISUSE WAS DETECTED, THIS REPORT IS BEING MADE DUE TO THE POSSIBILITY THAT THE USE OF AN INSULIN PUMP MAY HAVE CONTRIBUTED IN AN UNIDENTIFIED MANNER TO THE ALLEGED HYPERGLYCEMIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103222 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening