BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2233767 · Received September 3, 2011

    Report

    Report Number
    2531779-2011-06463
    Event Type
    Injury
    Date Received
    September 3, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 10/12/2011 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/15/2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY DEFECTS FOUND. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. EVALUATION ALSO 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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

    THE PATIENT REPORTED EXPERIENCING LOW BLOOD GLUCOSE (BG) WITH INCOHERENCY AND POSSIBLE LOSS OF CONSCIOUSNESS. THE PATIENT STATED THAT HE DOES NOT KNOW WHY HIS BG WENT LOW. THE PATIENT REPORTED THAT HIS BGS HAD BEEN WITHIN NORMAL RANGE, AND THEN AT 7:32 PM HIS BG WAS 69 MG/DL. HE STATED THAT HE BELIEVED HE WENT LOWER THAN THAT BECAUSE HE WAS INCOHERENT, BUT DID NOT HAVE FURTHER BG VALUES FOR THE INCIDENT AS HE HAD THROWN HIS METER REMOTE AND HIS WIFE AND BROTHER COULD NOT FIND IT. AT THE TIME OF THE CALL TO ANIMAS (B)(4), THE PATIENT'S BG WAS REPORTEDLY 61 MG/DL. HE STATED THAT HE DRANK ORANGE JUICE AND HIS BG ROSE TO 192 MG/DL. (B)(4) REVIEWED THE PUMP WITH THE PATIENT AND FOUND ALL SETTINGS WERE CORRECT AND HISTORIES MATCHED. A REVIEW OF THE BOLUS HISTORY INDICATED THAT THE LAST BOLUS PRIOR TO THE REPORTED INCIDENT WAS AT 10:00 AM. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT'S ALLEGED HYPOGLYCEMIC EVENT WHILE USING 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 57 YR