ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS' SAMPLES TESTED WITH ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ASSAY ON A COBAS C 503 ANALYTICAL UNIT. DISCREPANT RESULTS FOR 1 PATIENT SAMPLE WERE PROVIDED. INITIAL RESULT: 214 U/L. THE INITIAL RESULTS DID NOT MATCH THE PATIENT'S CLINICAL STATUS, PROMPTING THE REPEAT OF THE SAMPLE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. 1ST REPEAT RESULT: 119 U/L. 2ND REPEAT RESULT: 92 U/L.

Additional Manufacturer Narrative

THE ALKALINE PHOSPHATASE REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE QC WITHIN THE ASSIGNED RANGES ON THE DAY OF THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

MEDWATCH FIELD B6 WAS UPDATED. IN THE INITIAL MDR, THE FIRST LINE OF B5 DESCRIBE EVENT OR PROBLEM SHOULD HAVE BEEN: "WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE". INSTEAD OF: "WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS' SAMPLES". THE QCS WERE ACCEPTABLE. THE FIELD SERVICE ENGINEER INSPECTED THE SAMPLE PROBE AND THE MIXER RINSE STATION AND FOUND NO SIGNS OF CONTAMINATION OR CRYSTALLIZATION. HE THEN ASSESSED THE RINSE ARM LEVELS, THE CONTROLS, AND THE CUSTOMER VALIDATION, AND THEY WERE ACCEPTABLE. SINCE THE PROVIDED DATA FOR CALIBRATION AND QC WERE WITHIN SPECIFICATION AND NO FINDINGS FROM THE ONSITE EQUIPMENT INSPECTION, A GENERAL REAGENT OR HARDWARE-RELATED ISSUE CAN BE EXCLUDED. THERE WAS NO INDICATION OF A PRODUCT ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH A PREANALYTIC ISSUE (HIGH LEUKOCYTE CONCENTRATION OF THE SAMPLES, LEADING TO AN ACCUMULATION OF CELLS NEAR THE PLASMA SURFACE) AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY.