LIPASE COLORIMETRIC ASSAY

Additional Manufacturer Narrative

THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE LIPASE COLORIMETRIC ASSAY RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER ALLEGED THERE WAS A POTENTIAL INTERFERENCE. THE RESULTS WERE 33.6 U/L AND 34.6 U/L > ACCOMPANIED BY DATA FLAGS. A MANUAL 1:20 DILUTION 1WAS PERFORMED AND THE RESULT WAS 27.9 U/L ( X 20 = 558 U/L). THE SAMPLE WAS RETESTED UNDILUTED ON ANOTHER ANALYZER, AND THE RESULT WAS 35.7 U/L. A NEW MANUAL 1:10 DILUTION WAS PERFORMED, AND THE RESULTS WERE 40.9 U/L WITH A DATA FLAG (X 10= 409 U/L) AND 41.7 U/L (X 10=417 U/L). ON (B)(6) 2025, A NEW SAMPLE WAS COLLECTED FROM THE PATIENT, AND THE RESULTS WERE 34.1 U/L AND 34.5 U/L. A NEW 1:10 MANUAL DILUTION WAS PERFORMED, AND THE RESULTS WERE 40.5 U/L WITH A DATA FLAG ( X 10=405), 40.8 U/L ( X 10=408), AND 42.6 U/L (X 10=426).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH A GAMMOPATHY. PER PRODUCT LABELING FOR THE ASSAY: IN VERY RARE CASES, GAMMOPATHY, IN PARTICULAR TYPE IGM (WALDENSTRÖM¿S MACROGLOBULINEMIA), MAY CAUSE UNRELIABLE RESULTS. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION.