BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METER

    MDR report key: 1836369 · Received September 16, 2010

    Report

    Report Number
    2939301-2010-08036
    Event Type
    Injury
    Date Received
    September 16, 2010
    Report Date
    September 9, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K) # IS K043197. SERIAL# OF METER WAS NOT PROVIDED. DATE OF EVENT WAS ALSO NO PROVIDED. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS VIA EMAIL ON (B)(6) 2010 ALLEGING INACCURATE LOW READINGS ON HER METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION: BASED ON THE LETTER THE PATIENT MENTIONED THAT HER TEST STRIPS DID NOT SEEM TO BE WORKING AND THEY LOOKED DIFFERENT. SHE HAD TESTED HER BLOOD GLUCOSE AND OBTAINED A 275 MG/DL AND BASED ON THE METER RESULT SHE TOOK AN UNSPECIFIED AMOUNT OF INSULIN AND 10 MINUTES LATER, FELT SYMPTOMS OF "LOW BLOOD SUGAR" AND RETESTED AND OBTAINED A 298 MG/DL. SHE DID NOT TAKE ANY ACTION; HOWEVER ENDED UP FALLING INTO A COMA FOR AN HOUR. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THIS EVENT IN THE EMAIL. IT IS UNKNOWN ON WHETHER THE PATIENT REGAINED CONSCIOUSNESS ON HER OWN OR WHETHER SOMEONE FOUND HER. SHE THEN STATED THAT SHE CHECKED HER BLOOD GLUCOSE AGAIN AND IT READ 225 MG/DL AND THEN OPENED A NEW VIAL OF TEST STRIPS AND THE METER DISPLAYED A RESULT OF 80 MG/DL. SHE REQUESTED IN HER EMAIL REPLACEMENT TEST STRIPS AND STATED THAT THE ORIGINAL TEST STRIPS SHE HAD BEEN USING WERE "BAD". IT IS UNKNOWN WHAT TYPE OF METER THE PATIENT HAD BEEN USING. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW HER DIABETES REGIMEN, READINGS PRIOR TO THE EVENT, HOW SOON AFTER SHE FELL IN A COMA, DETAILS OF HER REGAINING CONSCIOUSNESS, WHETHER SHE SOUGHT ANY MEDICAL ATTENTION AND INFORMATION ABOUT HER METER AND TEST STRIPS. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SHE ENDED UP IN A COMA AFTER TAKING INSULIN BASED ON AN ALLEGEDLY HIGH BLOOD GLUCOSE READING ON HER METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2957210

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R