BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2655083 · Received July 13, 2012

    Report

    Report Number
    2531779-2012-06432
    Event Type
    Injury
    Date Received
    July 13, 2012
    Report Date
    June 14, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 09/06/2012 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/08/2012 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THERE WERE NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION RECORDED IN BLACK BOX OR ALARM HISTORY. THERE WAS AN EMPTY CARTRIDGE ALARM RECORDED ON (B)(6) 2012 07:19AM. DURING THE CARTRIDGE CHANGE, THE PUMP WAS POWERED OFF AND THE TIME AND DATE RESET TO DEFAULT SETTING. THE TIME AND DATE WAS THEN SET INCORRECTLY TO (B)(6) 2012 12:00AM. PUMP CONTINUED TO RUN ON INCORRECT DATE AND TIME UNTIL IT WAS CORRECTED AND CHANGED FROM (B)(6) 2012. THE REWIND, LOAD, PRIME STEPS WERE PERFORMED AND PASSED. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST AND WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP. THERE WAS NO DEFECT FOUND WITH THE ORIGINAL COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ALLEGING THAT A "FEW DAYS AGO" THE PATIENT HAD EXPERIENCED A LOW BLOOD GLUCOSE (BG) OF 25 MG/DL WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT REPORTEDLY DRANK MILK HAD CONSUMED SOME CHOCOLATE SYRUP, AND HER BG RESOLVED. THE REPORTER NOTED THAT THE PATIENT HAS AN INCONSISTENT DIET AND POOR DIABETES MANAGEMENT. THE REPORTER DENIED ANY ISSUES WITH THE PUMP AND WAS UNSURE WHY THE PATIENT'S BG WAS SO LOW. DURING TROUBLESHOOTING THE REPORTER CONFIRMED THAT THE TIME ON THE PUMP WAS CORRECT, BUT THE DATE WAS (B)(6) 2012 INSTEAD OF (B)(6) 2012. THE REPORTER WAS ABLE TO CORRECT THE DATE WHILE ON THE PHONE WITH CUSTOMER SUPPORT. THE REPORTER DID NOT THINK THAT THE DATE DISCREPANCY CONTRIBUTED TO THE LOW BG. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A BG INDICATIVE OF SEVERE HYPOGLYCEMIA DUE TO UNKNOWN CAUSES WHILE ON INSULIN PUMP THERAPY.

    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 17 YR Life Threatening