BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMYL GEN.2

    MDR report key: 9982412 · Received April 21, 2020

    Report

    Report Number
    1823260-2020-01083
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    March 27, 2020
    Report Date
    June 4, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFJ
    PMA / PMN Number
    K972250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT THAT IS DESCRIBED IN THE CASE HAS RECEIVED THE DRUG OBISPAX WITH THE CHEMICAL COMPONENT 'OTILONIUMBROMIDE'. THIS DRUG IS ADMINISTERED TO PATIENTS SUFFERING FROM 'INFLAMMATORY BOWEL DISEASE' (IBD). TWO PUBLICATIONS DESCRIBING THE IBD INDICATE THAT ELEVATED CONCENTRATIONS OF LIPASE AND OF AMYLASE ARE SEEN NOT ONLY IN PATIENTS WITH PANCREATITIS BUT ALSO IN PATIENTS WITH IBD. CONSEQUENTLY, ELEVATED SERUM LEVELS FOR LIPASE AND FOR AMYLASE ARE NOT SUFFICIENT MARKERS TO DIFFERENTIATE BETWEEN THE TWO DISEASES. IN THE PACKAGE INSERT FOR THE DRUG OBISPAX (ATTACHMENT: OBISPAX ® - PACKUNGSBEILAGE _ MEDIZINISCHES JOURNAL DER GESUNDHEIT.PDF) IT IS STATED THAT THE TREATMENT WITH THE DRUG WILL INFLUENCE THE LEVEL OF SEVERAL ENZYMES AND OF BILIRUBIN IN THE SERUM UNDER DRUG TREATMENT. THIS IS NOT AN ANALYTICAL INTERFERENCE BY THE DRUG. IT IS THE INFLUENCE OF THE DRUG CAUSED BY THE MODIFICATION OF THE BIOCHEMICAL PROCESSES IN THE BODY. IN THIS CASE IT COULD BE ASSUMED THAT THE ADMINISTRATION OF 'OTILONIUMBROMIDE' WILL REDUCE THE PATIENTS PAIN LEADING TO THE REDUCTION OF THE MEASURED VALUES FOR LIPASE AND FOR AMYLASE IN THE SERUM BEFORE AND AFTER DRUG TREATMENT. THE REDUCTION OF THE ABDOMINAL PAIN IN THE PATIENT GOES ALONG WITH THE REDUCTION OF THE LIPASE AND OF AMYLASE IN THE PATIENT'S SERUM. IN CONCLUSION IT CAN BE STATED THAT THE CHANGE IN THE CONCENTRATION FOR LIPASE AND FOR AMYLASE DESCRIBED IN THIS CASE IS NOT CAUSED BY AN ANALYTICAL PROBLEM WITH THE ROCHE ASSAYS. THE MEASURED VALUES FOR LIPASE AND FOR AMYLASE ARE MOST PROBABLY CORRECT. THE CHANGE OF THE CONCENTRATION IN THE TWO SAMPLES IS CAUSED BY THE CHANGE OF THE MEDICAL CONDITIONS OF THE PATIENT CAUSED BY THE DRUG TREATMENT. DRUG INTERFERENCE CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    REFER TO THE MEDWATCH WITH SUBMISSION NUMBER 1823260-2020-01084 FOR THE LIPASE ASSAY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). QUALITY CONTROL WAS ACCEPTABLE (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE HIGH AMYL2 -AMYLASE EPS VER.2 RESULTS FOR ONE PATIENT FROM A COBAS C 503 MODULE, SERIAL NUMBER (B)(4). THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULTS BASED ON THE PATIENT'S MEDICATION, BROMOCTYL. THE PATIENT RESULTS WERE NOT FROM A SINGLE PATIENT TUBE, A NEW SAMPLE TUBE WAS DRAWN FOR EACH DATE OF TESTING. REFER TO THE ATTACHMENT ON THE MEDWATCH FOR ALL PATIENT DATA. THIS MEDWATCH IS FOR AMYLASE. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR THE LIPASE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448061 AMYL GEN.2 AMYLASE TEST SYSTEM JFJ ROCHE DIAGNOSTICS AMYL G2 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 BROMOCTYL.