BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSE MONITORING SYS/KIT

    MDR report key: 1013128 · Received March 14, 2008

    Report

    Report Number
    2939301-2008-00288
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 26, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # 2756498 IS NOT A VALID LOT #. LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVAL IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION. LIFESCAN WILL INFORM THE FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LIFESCAN (LFS) IN 2008 ALLEGING INACCURATE HIGH READINGS ON THE PT'S ONE TOUCH ULTRA METER. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT F/U QUESTIONS AND OBTAINED THE FOLLOWING INFO: ON THE DAY BEFORE AT 6:00 PM, THE PT TESTED HER BLOOD GLUCOSE PRIOR TO DINNER AND OBTAINED A 248 MG/DL AND DID NOT EXHIBIT ANY SYMPTOMS. SHE COULD NOT BELIEVE THAT SHE HAD OBTAINED AN ELEVATED READING AND RETESTED AGAIN AND OBTAINED A 243 MG/DL AND DID NOT EXHIBIT ANY SYMPTOMS. SHE THEN TOOK 10 UNITS OF NOVORAPID INSULIN; INSTEAD OF 11 UNITS BECAUSE THE RESULT WAS A LITTLE ABOVE THE UPPER LIMIT. SHE THEN ATE DINNER. SHE DID NOT KNOW HOW TO CALCULATE CARBOHYDRATES; THEREFORE, DID NOT KNOW HOW MUCH CARBOHYDRATES SHE HAD FOR DINNER. SHE DOES NOT KEEP A LOG OF HER MEALS; AND THINKS FOR DINNER SHE ATE TWO SLICES OF BREAD, MEAT AND CHEESE. AT ABOUT 10:00 PM, SHE EXHIBITED SYMPTOMS OF FEELING SWEATY, SHAKING IN HER KNEES AND HEART PALPITATION. SHE IMMEDIATELY TOOK SOME DEXTROSE AND FELT BETTER AFTER 15 MINS. SHE DID NOT TEST HER BLOOD GLUCOSE AFTER SELF-TREATMENT. SHE THEN TOOK HER SET AMOUNT OF LANTUS INSULIN AT 10:30 PM. SHE ONLY TESTED HER BLOOD GLUCOSE THE FOLLOWING MORNING WITH A RESULT OF 111 MG/DL AT 8:00 AM. A NORMAL BLOOD GLUCOSE READING FOR THE PT IS BETWEEN 100-160 MG/DL. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. A QC TEST WAS DONE AND THE TEST STRIPS PASSED USING THE CONTROL SOLUTION. CUSTOMER CARE ADVOCATE (CCA) SENT THE PT A REPLACEMENT METER, STRIPS AND CONTROL SOLUTION. THE COMPLAINT IS BEING REPORTED SINCE THE PT ALLEGED THAT SHE TOOK INSULIN BASED ON AN ELEVATED READING AND LATER DEVELOPED SYMPTOMS THAT SUGGESTED HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening