BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3052191 · Received April 11, 2013

    Report

    Report Number
    2954323-2013-00212
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 22, 2013
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE COMPLAINT INVOLVED A DELIVERY ISSUE; HENCE NO PRODUCT INVESTIGATION WILL BE UNDERTAKEN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. IT SHOULD BE NOTED THAT IT IS KNOWN THAT THE SYMPTOMS STARTED ON 1(B)(6) 2013, THE EXACT DATE WHEN CUSTOMER WAS HOSPITALIZED IN UNKNOWN.

    Additional Manufacturer Narrative · 1

    CALLER CONTACTED ADC AGAIN ON (B)(6) 13 AND PROVIDED MORE INFORMATION ABOUT THE MEDICAL EVENT THAT OCCURRED WITH THE CUSTOMER ON (B)(6) 13. THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    REQUESTED TEST STRIPS WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1255349) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    THE METER HAS BEEN RECEIVED, THE METER'S INTERNAL MEMORY DATA DOWNLOAD WAS CONDUCTED AND IT WAS DETERMINED THAT FURTHER INVESTIGATION IS NEEDED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND INVESTIGATED. THE ER-3 ISSUE IS NOT CONFIRMED. A REVIEW OF THE METER'S LOG SHOWED SIXTEEN INSTANCES WHERE A USED/WET TEST STRIP WAS INSERTED INTO THE METER WITHIN A 37-MINUTE PERIOD. THE INVESTIGATION ALSO DETERMINED THE CAUSE OF THE ERRC-4 TO BE RELATED TO THE METER'S FIRMWARE. ALTHOUGH THE METER GENERATED AN ERROR MESSAGE, THE METER IS DESIGNED TO PRODUCE ERROR MESSAGES WHEN THE CHECKSUM IS INCORRECT. THE METER HAS A SOFTWARE TOOL USED TO VERIFY THE INTEGRITY OF THE METER'S SOFTWARE AND PREVENTS THE METER FROM GENERATING AN INCORRECT RESULT. THE INTENT OF THE ERROR MESSAGE IS TO PREVENT AN INCORRECT RESULT AND FOR WHICH LABEL COPY PROVIDES RECOMMENDATIONS ON TROUBLESHOOTING. LABEL COPY PROVIDES NARRATIVE TEXT TO EDUCATE USERS ON WHICH ERROR MESSAGES MAY APPEAR ON THE MONITOR'S DISPLAY WINDOW, WHAT THEY MEAN, AND WHAT THEY NEED TO DO AS A RESULT. IT SHOULD ALSO BE NOTED THAT THE USER GUIDE INSTRUCTS THE CUSTOMER TO PERFORM A CONTROL SOLUTION WHEN AN ER-4 MESSAGE IS OBSERVED, AND ADDITIONALLY TO CONTACT CUSTOMER SERVICE SHOULD THE ISSUE REOCCUR.

    Description of Event or Problem · 1

    CUSTOMER SERVICE WAS CONTACTED AGAIN ON (B)(6) 2013 AND CALLER INQUIRED ABOUT THE STATUS OF DELIVERY OF A REPLACEMENT METER. CALLER FURTHER STATED THAT THE MEDICAL EVENT THAT OCCURRED ON (B)(6) 2013 WAS RELATED TO CUSTOMER BEING UNABLE TO TEST DUE TO RECEIVING AN ER-3 AND ER-4 MESSAGE ON HER ADC METER AND CLARIFIED THAT THE MEDICAL EVENT WAS NOT RELATED TO DELIVERY ISSUE. CALLER ADDED THAT CUSTOMER HAD A LOSS OF CONSIOUSSNESS. CALLER ALSO PROVIDED MORE DETAILS ABOUT TREATMENT AT A LOCAL HEALTH CARE FACILITY STATING THAT CUSTOMER RECEIVED AN INTRAVENOUS SOLUTION WITH INSULIN. IT WAS FURTHER REPORTED THAT WHILE CUSTOMER WAS AT A LOCAL HEALTH CARE FACILITY FOR 2 DAYS "HER GLUCOSE LEVEL WAS FLUCTUATING, SOMETIMES LOW AND SOMETIMES HIGH HOWEVER HOSPITAL WAS ABLE TO MANAGE AND STABILIZED THE BLOOD GLUCOSE LEVEL".

    Description of Event or Problem · 1

    CALLER, BELIEVED TO BE THE CUSTOMER'S SON, REPORTED THAT CUSTOMER WAS UNABLE TO CHECK HER BLOOD GLUCOSE LEVEL DUE TO NOT RECEIVING A REPLACEMENT ADC METER WHEN EXPECTED. IT WAS FURTHER REPORTED THAT CUSTOMER'S BLOOD GLUCOSE LEVEL WAS "TOO HIGH" AND SHE WAS HOSPITALIZED FOR 2 DAYS. CALLER STATED THAT CUSTOMER WAS GIVEN JUICE BECAUSE IT WAS UNKNOWN WHETHER CUSTOMER HAD LOW BLOOD GLUCOSE. CUSTOMER WAS TREATED AT A LOCAL HEALTHCARE FACILITY, HOWEVER, FURTHER DETAILS ARE UNKNOWN BECAUSE CALLER DECLINED TO CONTINUE WITH MEDICAL SURVEY QUESTIONS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156490 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1255349

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization