BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4731088 · Received April 27, 2015

    Report

    Report Number
    2531779-2015-14102
    Event Type
    Injury
    Date Received
    April 27, 2015
    Date of Event
    April 9, 2015
    Report Date
    April 14, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    FOLLOW-UP #1: DATE OF SUBMISSION 06/24/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/09/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED AN UNEXPLAINED POWER EVENT ON 04/14/2015 AT 22:17, AND THE PUMP WAS TURNED BACK ON AT 22:28 ON 04/15/2015. ADDITIONALLY, A MANUAL TIME/DATE CHANGE WAS MADE FROM 04/15/2015 22:28 TO 04/13/2015 22:32. NO DISCREPANCIES WERE FOUND IN THE BLACK BOX OR PUMP HISTORIES FOR THE DATE OF THE ALLEGED INCIDENT. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP POWERED ON NORMALLY AND SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 2.0UNIT/HOUR BASAL RATE, AND AT THE END THE BASAL HISTORY CORRECTLY REFLECTED 2.0UNITS PER HOUR AND THE TOTAL DAILY DOSE HISTORY CORRECTLY REFLECTED 48.0UNITS. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. 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

    ON (B)(6) 2015 THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2015 THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF 466MG/DL WITH NAUSEA, SYMPTOMS OF DEHYDRATION, EXCESS URINATION, AND EXTREME THIRST. REPORTEDLY, THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT AND THE PATIENT DISCONTINUED INSULIN PUMP THERAPY. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE REPORTER. TROUBLESHOOTING INDICATED THAT THE BASAL HISTORY MATCHED THE ACTIVE BASAL PROGRAM, BUT THAT THE BASAL DELIVERY TOTALS IN THE TOTAL DAILY DOSE HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM TOTAL. TROUBLESHOOTING COULD NOT DETERMINE A CAUSE FOR THE VARIATION. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN ALLEGED HISTORY/SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277197 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening