BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1570972 · Received January 6, 2010

    Report

    Report Number
    2954323-2010-00017
    Event Type
    Injury
    Date Received
    January 6, 2010
    Date of Event
    December 10, 2009
    Report Date
    July 13, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE "DATE RECEIVED BY MANUFACTURER" ON FOLLOW-UP #1 REPORT SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2010. AS PER THE ARRANGEMENTS DISCUSSED WITH (B)(4) AT FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(4) 2011 LETTER ADDRESSED TO (B)(6).

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (B)(4) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER REPORTED THE CUSTOMER RECEIVED THE FOLLOWING READINGS ON HER BLOOD GLUCOSE METER IN 2009: 97 MG/DL (06:45 A.M.), 492 MG/DL (07:30 A.M.), 400 MG/DL (07:45 A.M.) AND 440 MG/DL (08:15 A.M.). THE CUSTOMER'S DAUGHTER ADDITIONALLY REPORTED THE CUSTOMER RECEIVED A READING OF 400 MG/DL PRIOR TO THE MEDICAL EVENT. DUE TO HIGH BLOOD GLUCOSE READINGS, THE CUSTOMER REPORTEDLY TOOK HER INSULIN MEDICATION AND THEN BECAME INCOHERENT WITH SYMPTOMS OF HYPOGLYCEMIA. THE PARAMEDICS WERE CALLED AND THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS TOO LOW TO OBTAIN A READING. THE CUSTOMER WAS REPORTEDLY TRANSPORTED TO A HOSPITAL WHERE SHE WAS TOLD HER BLOOD GLUCOSE LEVEL WAS LOW (NO BLOOD GLUCOSE READING AND NO MEDICAL DIAGNOSIS IS AVAILABLE), AND AN INTRAVENOUS GLUCOSE MEDICATION WAS ADMINISTERED TO THE CUSTOMER. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(4) REGARDING PERITONITIS IN A (B)(6) FEMALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. ON (B)(6)2010, THE PATIENT EXPERIENCED PERITONITIS, WHICH DID NOT REQUIRE HOSPITALIZATION. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6)2010, A PERITONEAL EFFLUENT CULTURE AND ANALYSIS WERE PERFORMED, PRIOR TO THE INITIATION OF ANTIBIOTIC THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH FORTUM AND REFLIN INTRAPERITONEALLY. ON (B)(6)2010, THE EVENT OF PERITONITIS RESOLVED. PD THERAPY CONTINUED. MEDICAL HISTORY INCLUDED END STAGE RENAL DISEASE (ESRD), HYPERTENSION AND DIABETES. THE NURSE BELIEVED THE EVENT OF PERITONITIS WAS UNRELATED TO PD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW 0926308

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R