BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2761165 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11317
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. 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. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS A TIME/DATE RESET ON (B)(4) 2012 AT 12:15 FOR A BATTERY CHANGE. WHEN THE PUMP WAS POWERED BACK ON, THE TIME/DATE WAS SET TO (B)(4) 2012 00:25. A MANUAL TIME/DATE CHANGE WAS ALSO OBSERVED ON (B)(4) 2012 FROM 17:34 TO 5:35, AND AGAIN ON (B)(4) 2012 FROM 12:39 TO (B)(4) 2012 12:39. A REVIEW OF THE TOTAL DAILY DOSE HISTORY APPEARS INACCURATE ON THE DAYS THAT THE TIME AND DATE WAS ADJUSTED INCORRECTLY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE TIME DID NOT CHANGE FROM AM TO PM ON ITS OWN DURING TESTING. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS TO REPORT THAT FOR THREE WEEKS, THE REPORTED PUMP WOULD INTERMITTENTLY SWITCH THE TIME SETTING AM VS. PM WITHOUT USER INTERVENTION. THE PATIENT REPORTED THAT AFTER A BATTERY REPLACEMENT, SHE WOULD VERIFY AND CORRECT THE PUMP DATE/TIME. THE PATIENT ALLEGED THAT AFTER SHE HAD CORRECTLY SET THE TIME, THE PUMP WOULD SELF-SWITCH THE AM/PM SETTING. AFTER THIS OCCURRED, THE PATIENT OBTAINED LOW BLOOD GLUCOSE LEVELS SUCH AS 42 MG/DL AND SHE EXPERIENCED THE SYMPTOMS OF IMPAIRED VISION, SWEATING AND "FELT HOT." THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING SUGAR, AND FELT BETTER AFTERWARDS. THE PATIENT ALSO REPORTED ELEVATED BLOOD GLUCOSE READINGS SUCH AS 400 MG/DL WITH THE SYMPTOM OF FREQUENT URINATION. TROUBLESHOOTING REVEALED THE PUMP'S BASAL RATE SETTING WAS CORRECT. THE PATIENT ALLEGEDLY SUFFERED BLOOD GLUCOSE LEVELS AND SYMPTOMS SUGGESTING SEVERE INJURY AFTER THE PUMP TIME SETTING CHANGED WITHOUT USER INTERVENTION. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening