BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLINICAL CHEMISTRY GLUCOSE

    MDR report key: 1954607 · Received January 10, 2011

    Report

    Report Number
    1628664-2011-00006
    Event Type
    Death
    Date Received
    January 10, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INQUIRED IF LEVOFLOXACIN IS A KNOWN INTERFERENT WITH THE ARCHITECT GLUCOSE ASSAY. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE REFERENCED THE ASSAY'S PACKAGE INSERT, WHICH DID NOT HAVE LEVOFLOXACIN LISTED AS AN INTERFERENT. THE CUSTOMER COMMENTED THAT THEY DID NOT FEEL THAT THE ISSUE WAS RELATED TO THE ARCHITECT GLUCOSE ASSAY RESULTS BEING INCORRECT. THE CUSTOMER STATED THAT IT MAY BE DUE TO THE PHLEBOTOMY TECHNIQUE/COLLECTION SITE DUE TO THE ADMINISTRATION OF THE TWO DRUGS. THIS WOULD NOT AFFECT THE POC RESULTS AS THE SAMPLES FOR THIS TECHNIQUE ARE FINGERSTICKS. THE CUSTOMER STATED THAT THERE IS NO SAMPLE FOR ANY FURTHER TESTING AND THAT ALL RESULTS WERE VERIFIED. THEREFORE, THE EVALUATION BEGAN WITH A REVIEW OF THE CLINICAL CHEMISTRY GLUCOSE (LIST NUMBER 3L82) PACKAGE INSERT, COMMODITY (B)(4), (B)(6) 2010. THE PACKAGE INSERT STATES THAT INTERFERENCES FROM MEDICATIONS OR ENDOGENOUS SUBSTANCES MAY AFFECT RESULTS. NO SPECIFIC INFORMATION WAS GIVEN ABOUT LEVOFLOXACIN AS AN INTERFERING SUBSTANCE FOR GLUCOSE ASSAYS. A LITERATURE SEARCH FOR LEVOFLOXACIN AS A KNOWN INTERFERENT WITH GLUCOSE ASSAYS WAS CONDUCTED. THE RESULTS DESCRIBE THE DYSGLYCEMIC, HYPOGLYCEMIC AND HYPERGLYCEMIC EFFECT OF LEVOFLOXACIN. NO SPECIFIC INFORMATION WAS GIVEN ABOUT LEVOFLOXACIN AS AN INTERFERING SUBSTANCE FOR ASSAYS. THE FOLLOWING INFORMATION WAS FOUND FOR LEVOFLOXACIN FROM THE PHYSICIAN'S DESK REFERENCE ((B)(4)): AS WITH OTHER FLUOROQUINOLONES, DISTURBANCE OF BLOOD GLUCOSE, INCLUDING SYMPTOMATIC HYPER AND HYPOGLYCEMIA, HAVE BEEN REPORTED WITH LEVAQUIN, USUALLY IN DIABETIC PATIENTS RECEIVING CONCOMITANT TREATMENT WITH AN ORAL HYPOGLYCEMIC AGENT (E.G., GLYBURIDE) OR WITH INSULIN. A REVIEW OF THE CERTIFICATES OF ANALYSIS (COA) FOR CLINICAL CHEMISTRY GLUCOSE LIST NUMBER 3L82, LOT NUMBER 91003HW00 WAS PERFORMED AND FOUND PASSING MANUFACTURING RELEASE SPECIFICATIONS. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE EVALUATION INDICATED THAT THE CLINICAL CHEMISTRY GLUCOSE ASSAY, LIST NUMBER 3L82 IS PERFORMING WITHIN SPECIFICATION. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. CONCOMITANT MEDICAL PRODUCTS: ARCH C16000 ANALYZER; LN: 3L77-01; SN: (B)(4). EVALUATION, METHOD: REVIEW OF COMPLAINT TRACKING AND TRENDING; MEDICAL LITERATURE SEARCH. PATIENT EVENT PROBLEM: (SEPSIS); (DIABETIC KETOACIDOSIS). DEVICE EVENT PROBLEM: (NO KNOWN DEVICE PROBLEM).

    Description of Event or Problem · 1

    THERE WAS NO SUSPECTED ASSOCIATION BETWEEN THE PATIENT DEATH REPORTED IN THIS INCIDENT AND THE DISCREPANT GLUCOSE RESULTS GENERATED BY THE ARCHITECT C8000 ANALYZER. THE CUSTOMER STATES THAT AN (B)(6) FEMALE PATIENT WAS BROUGHT INTO THE EMERGENCY ROOM UNRESPONSIVE. BLOOD SAMPLES TAKEN AND ANALYZED FOR GLUCOSE GENERATED RESULTS OF GREATER THAN 500 MG/DL ON A NON-ABBOTT POINT OF CARE (POC) ANALYZER AND A RESULT OF 642 MG/DL ON AN ARCHITECT C16000 ANALYZER. THE PATIENT WAS ADMITTED AND STARTED ON AN INSULIN DRIP AND AN INTRAVENOUS DELIVERY OF LEVOFLOXACIN (250 MG IN 5% DEXTROSE). APPROXIMATELY SIX HOURS LATER, ANOTHER BLOOD SAMPLE WAS TAKEN FOR GLUCOSE THAT GENERATED A POC VALUE OF 315 MG/DL AND AN ARCHITECT VALUE OF 780 MG/DL. THE HOSPITAL USES A NORMAL REFERENCE VALUE FOR A FASTING GLUCOSE OF LESS THAN 100 MG/DL. APPROXIMATELY THREE HOURS AND TWENTY MINUTES LATER, ANOTHER SAMPLE TAKEN FOR GLUCOSE GENERATED A POC VALUE OF 156 MG/DL AND AN ARCHITECT VALUE OF 1411 MG/DL. ALL ARCHITECT GLUCOSE VALUES WERE VERIFIED ON BOTH ARCHITECT C16000 ANALYZERS IN THE LAB AND CONTROLS WERE WITHIN SPECIFICATIONS ON ALL RUNS. THE PATIENT DIED THE FOLLOWING DAY WITH CAUSE OF DEATH LISTED AS DIABETIC ACIDOSIS AND UROSEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY GLUCOSE FOR THE QUANTITATION OF GLUCOSE IN HUMAN SERUM, PLASMA, URINE OR CSF NBW ABBOTT MANUFACTURING, INC. 91003HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death ARC C16000 ANALYZER LN: 3L77-01 SN: (B)(4)