BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2181831 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05377
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER/PHYSICIAN CONTACTED ANIMAS ON BEHALF OF THE PATIENT ALLEGING THAT THE PATIENT WAS IN THE HOSPITAL DUE TO THE PUMP "MALFUNCTIONING." THE (B)(4) MAILED A LETTER TO THE PATIENT ON (B)(6) 2011, REQUESTING HIM TO CALL BACK FOR FOLLOW-UP INFORMATION. AN ANIMAS REPRESENTATIVE MET WITH THE PATIENT ON AN UNSPECIFIED DATE/TIME TO TROUBLESHOOT THE PUMP. THE PATIENT REPORTEDLY RECEIVED AN OCCLUSION ALARM ON (B)(6) 2011, AT MIDNIGHT. HOWEVER, AT THE TIME, THE PATIENT STATED THAT HIS BLOOD GLUCOSE (BG) LEVEL WAS FINE AT THE TIME. THE PATIENT REPORTEDLY RECEIVED ANOTHER OCCLUSION ALARM ON (B)(6) 2011, AT 2:00 AM. AGAIN, THE PATIENT STATED THAT HIS BG WAS FINE AT THE TIME. THAT SAME EVENING, THE PATIENT CHANGED HIS SITE, TUBING, AND CARTRIDGE. THE PATIENT DENIED THAT HE RECEIVED ANY ADDITIONAL ALARMS THAT DAY BUT HIS BG'S WERE HIGH "ALL DAY." THE PATIENT REPORTEDLY DID NOT TRY TO BOLUS OR FOLLOW PROPER STEPS TO TROUBLESHOOT THE HIGH BG LEVEL. A REVIEW OF THE PUMP'S HISTORY REVEALED THAT NO BOLUSES WERE ADMINISTERED AFTER 8:30 AM ON (B)(6) 2011. THE PATIENT REPORTEDLY WENT TO THE HOSPITAL ON (B)(6) 2011. UPON ADMISSION, HIS BG LEVEL WAS "446 MG/DL." HE WAS ADMITTED FOR HYPERGLYCEMIA AND PLACED ON AN INSULIN DRIP. THE ANIMAS REPRESENTATIVE INVOLVED WITH THE CONTACT AND TROUBLESHOOTING OF THE PUMP INFORMED THE PHYSICIAN THAT THE PUMP WAS WORKING PROPERLY. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PHYSICIAN CLAIMED THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA AND THE PUMP WAS NOT WORKING PROPERLY.

    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 22 YR Hospitalization| L| R