BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2840945 · Received November 20, 2012

    Report

    Report Number
    2531779-2012-13819
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 27, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: 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. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT AND A REDDISH TINT ON THE DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. 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. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED WORN KEYPAD SYMBOLS.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT THAT FOR ONE MONTH THE PATIENT OBTAINED LOW BLOOD GLUCOSE READINGS DURING THE NIGHT SUCH AS 40 MG/DL, AND ELEVATED BLOOD GLUCOSE READINGS DURING THE DAY SUCH AS 400 MG/DL. THE PATIENT EXPERIENCED THE SYMPTOM OF EXTREME THIRST WHILE HAVING ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT ADMINISTERED SELF-TREATMENT WITH FOOD FOR HER LOW BLOOD GLUCOSE LEVELS AND CORRECTING BOLUS DOSES OF INSULIN FOR THE HYPERGLYCEMIC EPISODES. TROUBLESHOOTING REVEALED THE PUMP'S TIME WAS SET INCORRECTLY, AM FOR PM, WHICH WOULD CAUSE THE PATIENT TO BE RECEIVING HER BASAL RATE DOSES AT THE INCORRECT TIMES. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIM OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON, AND TO VERIFY THE DATE AND TIME ARE CORRECT AFTER A BATTERY REPLACEMENT. THE PATIENT'S TECHNIQUE WAS INCORRECT BY NOT VERIFYING THE CORRECT DATE/TIME ON THE PUMP SETTINGS. HOWEVER, AS THE PATIENT SUFFERED BLOOD GLUCOSE LEVELS AND SYMPTOMS SUGGESTING SEVERE INJURY AFTER THIS OCCURRED, 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 76 YR Life Threatening