BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK INFORM II TEST STRIPS

    MDR report key: 13254785 · Received January 13, 2022

    Report

    Report Number
    1823260-2022-00116
    Event Type
    Death
    Date Received
    January 13, 2022
    Date of Event
    April 18, 2020
    Report Date
    September 20, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    UDI-DI
    00365702428102
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS ASSESSED BY ROCHE MEDICAL PERSONNEL. RETROSPECTIVE CHART REVIEW IDENTIFIED THE PATIENT HAD RECEIVED IV HIGH-DOSE VITAMIN C INFUSION ONE DAY PRIOR TO PRESENTATION AT THE HOSPITAL, DOSE UNKNOWN. HIGH-DOSE IV VITAMIN C THERAPY IS KNOWN TO FALSELY ELEVATE GLUCOSE AND BETA-HYDROXYBUTYRATE IN HOSPITALIZED PATIENTS. FURTHER, HIGH-DOSE IV VITAMIN C THERAPY IS KNOWN TO FALSELY ELEVATE THE ACCU-CHEK INFORM II METER RESULT, A LIMITATION DISCLOSED IN PRODUCT LABELING. ALTHOUGH INTRAVENOUS VITAMIN C IS ELIMINATED BY FIRST-ORDER KINETICS WITH A HALF-LIFE OF APPROXIMATELY 2 HOURS , THIS PROCESS CAN BE IMPACTED BY IMPAIRED KIDNEY FUNCTION. SERUM ASCORBIC ACID LEVELS WERE NOT MEASURED IN THIS CASE TO CONFIRM CONCENTRATION DURING HOSPITALIZATION AND TREATMENT. OTHER CONCOMITANT MEDICATIONS/TREATMENTS ARE UNKNOWN IN THIS CASE. IT IS UNKNOWN WHY SEVERAL LABORATORY COMPARISON VALUES WERE DISREGARDED IN THIS CASE. REFERENCES: (1)CERIOTTI, F., KACZMAREK, E., GUERRA, E., MASTRANTONIO, F., LUCARELLI, F, VALGAMIGLI, F, & MOSCA, A. (2014). COMPARATIVE PERFORMANCE ASSESSMENT OF POINT-OF-CARE TESTING DEVICES FOR MEASURING GLUCOSE AND KETONES AT PATIENT BEDSIDE, 9(2): 268-277. (2)LYKKESFELDT, J., & TVEDEN-NYBORG, P. (2019). THE PHARMACOKINETICS OF VITAMIN C. NUTRIENTS, 11(10), 2412. ON A REGULAR BASIS, ACCU-CHEK INFORM STRIPS OF LOTS CURRENTLY VALID IN THE MARKET ARE TESTED AS PART OF ROUTINE RETENTION TESTING AND RESULTS HAVE PASSED THE INTERNAL INSPECTION. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE POINT OF CARE CO-ORDINATOR (POCC) AT WELLSTAR ATLANTA MEDICAL CENTER BUT WERE UNSUCCESSFUL. THEREFORE THE DEVICE HAS NOT BEEN REQUESTED FOR RETURN.

    Additional Manufacturer Narrative · 0

    THE PATIENT CODES WERE UPDATED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED RELATED TO THIS CASE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    WE RECEIVED A REPORT OF A JOURNAL ARTICLE FROM THE AACE (AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGY) CLINICAL CASE REPORTS OF A CASE OF A PATIENT DIAGNOSED WITH PSEUDOHYPERGLYCEMIA AND TREATED AS DIABETIC KETOACIDOSIS (DKA), DUE TO THE INTERFERENCE OF HIGH DOSE INTRAVENOUS (IV) VITAMIN C WITH INFORM II (POINT OF CARE (POC) BLOOD GLUCOSE (BG)) METER. THE PATIENT EVENTUALLY DIED, AND IT WAS ALLEGED THAT HYPOGLYCEMIA LIKELY CONTRIBUTED TO THE DEATH OF THE PATIENT. THE ARTICLE IS TITLED, "PSEUDOHYPERGLYCEMIA SECONDARY TO HIGH-DOSE INTRAVENOUS VITAMIN C MANAGED AS DIABETIC KETOACIDOSIS: AN ENDOCRINOLOGICAL CATASTROPHE". IT WAS AUTHORED BY ISRAEL B. ORIJA, MD, SYEDA HIRA ZAHID, MBBS, MD. THE ARTICLE PRESENTS A CASE WHERE A PATIENT WAS "ADMITTED FOLLOWING A SYNCOPAL EPISODE ASSOCIATED WITH AN ACUTE NON-ST ELEVATION MYOCARDIAL INFARCTION. SHE WAS FOUND TO HAVE SIGNIFICANT HYPERGLYCEMIA WITH BLOOD GLUCOSE >600 MG/DL ON THE ACCU-CHEK INFORM II METER (POC GLUCOSE METER), ASSOCIATED WITH MODERATE KETOACIDOSIS. SHE WAS TREATED WITH INTRAVENOUS INSULIN AS A CASE OF DKA. SHE DEVELOPED SEVERE HYPOGLYCEMIA, WHICH WAS CONFIRMED ON AN UNKNOWN VENOUS BG ANALYZER, AND HER CONDITION WAS COMPLICATED BY AN APPARENT STROKE-LIKE STATE. THE PATIENT DETERIORATED AND SUBSEQUENTLY DIED." THE ARTICLE STATES, "THE STRONG DISCREPANCY BETWEEN VENOUS AND POC-BG VALUES LED TO A SUSPICION OF INTERFERENCE WITH THE POC GLUCOSE METER. WE PERFORMED A RETROSPECTIVE ANALYSIS OF THE CASE WITH A THOROUGH CHART REVIEW AND DISCOVERED THAT PATIENT HAD BEEN ON IV HIGH-DOSE VITAMIN C INFUSION AS A NATURAL REMEDY FOR HER UTERINE CANCER. THIS WAS CONFIRMED VIA A TELEPHONE CONVERSATION WITH HER SON. SHE RECEIVED HER LAST DOSE ONE DAY PRIOR TO PRESENTATION AT OUR HOSPITAL. HE ALSO REPORTED THAT THE PATIENT HAD BEEN LOSING A LOT OF WEIGHT RECENTLY WITH POOR ORAL INTAKE AND PROGRESSIVE WEAKNESS." THE ARTICLE ALSO STATES, "WE DID NOT MEASURE SERUM ASCORBIC ACID LEVELS IN OUR PATIENT." THE ARTICLE STATES, "CONCLUSION: POC-BG MONITORING IS VERY COMMONLY USED IN INTENSIVE CARE UNIT SETTINGS TO MONITOR BG AS THEY ARE MINIMALLY INVASIVE, CONVENIENT, AND QUICK. HOWEVER, PHYSICIANS AND NURSES NEED TO BE AWARE THAT CERTAIN SUBSTANCES CAN INTERFERE WITH AND ALTER POC-BG LEVELS, LEADING TO INCORRECT DIAGNOSIS OF PSEUDOHYPERGLYCEMIA OR PSEUDOHYPOGLYCEMIA. THIS MAY POTENTIALLY LEAD TO CATASTROPHIC CONSEQUENCES AND RESULT IN INCREASED MORBIDITY AND MORTALITY IN INTENSIVE CARE UNIT SETTINGS. THE FOOD AND DRUG ADMINISTRATION ADVISES AGAINST THE USE OF POC-BG METERS IN CRITICAL SETTINGS, AND THEY SHOULD NEVER BE USED TO DIAGNOSE DKA." THE LIMITATIONS SECTION OF THE PRODUCT LABELING STATES THE FOLLOWING: "INTRAVENOUS ADMINISTRATION OF ASCORBIC ACID WHICH RESULTS IN BLOOD CONCENTRATIONS OF ASCORBIC ACID >3 MG/DL WILL CAUSE OVERESTIMATION OF BLOOD GLUCOSE RESULTS." "THE SYSTEM HAS NOT RECEIVED FDA CLEARANCE FOR USE WITH PATIENTS RECEIVING INTENSIVE MEDICAL INTERVENTION OR THERAPY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784332 ACCU-CHEK INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU 00365702428102

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death