AMYL GEN.2

Additional Manufacturer Narrative

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

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

Additional Manufacturer Narrative

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

Description of Event or Problem

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.