IMMAGE® IMMUNOCHEMISTRY SYSTEM

Description of Event or Problem

THE CUSTOMER REPORTED THAT ON (B)(6) 2011, ERRONEOUS PREALBUMIN (PAB) AND/OR TRANSFERRIN (TRF) RESULTS WERE GENERATED ON AN IMMAGE IMMUNOCHEMISTRY SYSTEM FOR MULTIPLE PATIENT SAMPLES. THE EXACT NUMBER OF INVOLVED PATIENT SAMPLES IN UNKNOWN. ALTHOUGH THE CUSTOMER INDICATED THAT IMMUNOGLOBULIN G (IGG) AND C-REACTIVE PROTEIN (CRP) QUALITY CONTROL RESULTS WERE DISCREPANT, THE CUSTOMER DID NOT INDICATE OR PROVIDE EVIDENCE THAT ANY IGG AND CRP PATIENT RESULTS WERE AFFECTED. DATA PROVIDED BY THE CUSTOMER INDICATED THE GENERATION OF ELEVEN PAB RESULTS AND TWO TRF RESULTS. NO EVIDENCE OF DISCREPANT IMMUNOGLOBULIN G (IGG) AND C-REACTIVE PROTEIN (CRP) RESULTS WAS PROVIDED. IN SEVEN CASES, THE REPEAT PAB RESULTS WERE LOWER AND REGARDED VALID. IN BOTH CASES, THE REPEAT TRF RESULTS WERE LOWER AND CONSIDERED VALID. IN ONE CASE, THE REPEAT PAB RESULT WAS HIGHER THAN THE INITIAL PAB RESULT. IN THREE CASES THE PAB INITIAL RESULTS WAS NOT REPEATED AND HENCE THE INITIAL RESULTS WERE NOT CONFIRMED AS ERRONEOUS BY REPEAT TESTING. THE ERRONEOUS INITIAL RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND HENCE THERE WERE NO DEATHS, SERIOUS INJURIES OR CHANGE TO PATIENTS' TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. SAMPLES WERE SERUM. PAB, TRF, IGG AND CRP QUALITY CONTROL (QC) RESULTS DURING THE TIMEFRAME OF THE EVENT WERE "HIGH" UPON INITIAL RUN AS WELL AS ON A RERUN ATTEMPT AFTER IMPLEMENTING NEW REAGENT PACKS AND CONTROLS. AFTER PRIMING THE INSTRUMENT, ALL ASSAY QC RESULTS WERE WITHIN ESTABLISHED RANGES.

Additional Manufacturer Narrative

SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011, FOR THIS EVENT. THE FSE REPLACED THE REAGENT PROBE, SAMPLE PROBES AND LEVEL SENSE BOARDS FOR PROBES. THE FSE REPLACED THE MIXER PADDLES, AND CUVETTE WASH HEAD. AFTER THE REPAIRS, THE FSE PERFORMED INSTRUMENT PERFORMANCE VERIFICATION ASSESSMENTS WHICH MET SPECIFICATIONS. MDR ASSOCIATED WITH THIS EVENT: 2050012-2011-02578, 2050012-2011-04955.