BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2162426 · Received July 14, 2011

    Report

    Report Number
    2531779-2011-04954
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PATIENT) AND REPORTED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE REPORTER ON (B)(6) 2011, AND WAS ABLE TO OBTAIN/VERIFY INFORMATION. THE REPORTER INDICATED THAT THE PATIENT HAD GOTTEN TWO LOSS OF PRIME WARNINGS (B)(6). ON (B)(6) 2011, THE REPORTER CLAIMED THAT THE PATIENT OBTAINED 3 ADDITIONAL LOSS OF PRIME WARNINGS. THAT SAME MORNING, THE REPORTER STATED THAT THE PATIENT'S BG LEVEL WAS NORMAL. THE PATIENT LAST CHANGED HER SITE ON (B)(6) 2011, AT AN UNSPECIFIED TIME. IN THE AFTERNOON OF (B)(6) 2011, THE REPORTER MENTIONED THAT THE PATIENT'S BG LEVEL ELEVATED TO "300 MG/DL" AND SHE HAD DEVELOPED KETONES. THROUGH TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE INVOLVED IN THIS CONTACT DETERMINED THAT THERE WAS NO EVIDENCE OF A MECHANICAL MALFUNCTION WITH THE PUMP. THE ANIMAS REPRESENTATIVE ADVISED THE REPORTER TO CHANGE THE PATIENT'S SITE AND TO CALL ANIMAS BACK IF THE PATIENT'S BG LEVELS WERE NOT RESOLVED. THE REPORTER INFORMED THE MSS THAT SHE FEELS AS THE PATIENT'S ELEVATED BG LEVEL WAS DUE TO A SITE ISSUE. THE REPORTER STATED THAT THE PATIENT'S BG LEVEL CAME DOWN AFTER A CORRECTION WAS GIVEN VIA SYRINGE AND THE PATIENT'S SITE WAS CHANGED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED AN ELEVATED BG LEVEL AND KETONES. THE PATIENT'S INJURY CAN BE ATTRIBUTED TO USE-ERROR SINCE HER BG LEVELS WERE RESOLVED WITH A SITE CHANGE.

    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 3 YR Life Threatening