BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3120630 · Received May 20, 2013

    Report

    Report Number
    2531779-2013-06739
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/29/2013 -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¿S HISTORY SHOWED MULTIPLE EXCEEDS MAXIMUM TOTAL DAILY DOSE LIMIT WARNINGS ON 04/24/2013. THE TOTAL DAILY DOSE SHOWED THE HIGHEST COUNT AND THE BOLUS HISTORY SHOWED 9 COMBO BOLUSES PERFORMED BY THE PUMP. THE TOTAL DAILY DOSES CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. DURING TESTING, THE PUMP POWERED ON NORMALLY AND DISPLAYED THE VERIFY SCREEN. THE PUMP WAS PAIRED WITH THE METER AND EXERCISED FOR 24 HOURS WITH NO DELIVERY INTERRUPTION. BOLUSES WERE PERFORMED USING THE NORMAL, EZ CARB, EZ BG, AND COMBO BOLUSES; ALL BOLUSES WERE RECORDED ACCURATELY IN THE CORRECT TIME AND ORDER IN THE PUMP¿S HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. THERE WAS NO DAMAGE TO THE KEYPAD AND ALL KEYPAD BUTTONS RESPONDED PROPERLY TO PRESSES.

    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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING LOW BLOOD GLUCOSE (BG) OF 44 MG/DL WITHOUT SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA. THIS REPORTED LOW BG DOES NOT MEET ANIMAS¿ CRITERIA OF A REPORTABLE ADVERSE EVENT. THE PATIENT STATED THAT HE CONSUMED TWO CANDY BARS AS TREATMENT OF THE LOW BG. THE PATIENT ALLEGED FOUR BOLUSES IN THE PUMP¿S BOLUS HISTORY THAT HE CLAIMED HE DID NOT PROGRAM. REVIEW OF THE PUMP¿S BOLUS HISTORY REVEALED A COMBO-BOLUS OF 4.0 UNITS, A COMBO-BOLUS OF 4.0 UNITS AT 12:40 PM; A COMBO-BOLUS OF 4.0 UNITS AT 1:34 PM; AND A COMBO-BOLUS OF 6.0 UNITS AT 3:50 PM. THE PATIENT DENIED ANY ISSUES INVOLVING THE KEYPAD. THE PATIENT DISCONTINUED INSULIN PUMP THERAPY AND BEGAN ON A BACKUP PLAN FOR INSULIN DELIVERY AS RECOMMENDED BY THE HEALTHCARE PROVIDER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED THE PUMP DELIVERED AND RECORDED COMBO-BOLUSES THAT WERE NOT PROGRAMMED BY THE USER AND THIS ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221463 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR