PHOS2 PHOSPHATE (INORGANIC) VER.2

Additional Manufacturer Narrative

THE ALARM TRACE SHOWED MULTIPLE ABNORMAL ASPIRATION ALARMS. THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH PHOS2 PHOSPHATE (INORGANIC) VER.2 ON A TWO COBAS 8000 C 502 MODULE ANALYZERS AND AN UNKNOWN ROCHE COBAS CLINICAL CHEMISTRY ANALYZER. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED WITH A PHOSPHORUS VALUE OF 7.65 MG/DL WHEN TESTED ON THE FIRST C 502 ANALYZER. THE SAMPLE WAS REPEATED ON AN UNKNOWN COMPETITOR DRY CHEMISTRY SYSTEM, RESULTING WITH A VALUE OF 3.1 MG/DL ON (B)(6) 2019. THE SAMPLE WAS REPEATED ON AN UNKNOWN ROCHE CLINICAL CHEMISTRY ANALYZER, RESULTING WITH A VALUE OF 8.16 MG/DL ON (B)(6) 2019. THE SAMPLE WAS ALSO REPEATED ON A SECOND C 502 ANALYZER, RESULTING WITH A VALUE OF 8.0 MG/DL ON (B)(6) 2019. THE SECOND SAMPLE INITIALLY RESULTED WITH A PHOSPHORUS VALUE OF 4.63 MG/DL WHEN TESTED ON THE FIRST C 502 ANALYZER ON (B)(6) 2019. THE SAMPLE WAS REPEATED ON AN UNKNOWN COMPETITOR DRY CHEMISTRY SYSTEM, RESULTING WITH A VALUE OF 2.6 MG/DL. THE SAMPLE WAS ALSO REPEATED ON A SECOND C 502 ANALYZER, RESULTING WITH A VALUE OF 4.54 MG/DL ON (B)(6) 2019. THE SERIAL NUMBER OF THE FIRST C 502 ANALYZER WAS (B)(4). THE SERIAL NUMBERS OF THE SECOND C 502 ANALYZER AND UNKNOWN ROCHE CLINICAL CHEMISTRY ANALYZER WERE REQUESTED, BUT NOT PROVIDED.

Additional Manufacturer Narrative

THE CALIBRATION DATA WAS ACCEPTABLE. THE QC DATA ARE WITHIN SPECIFICATIONS. A REAGENT ISSUE IS NOT LIKELY. THE ISSUE IS CONSISTENT WITH A PRE-ANALYTIC HANDLING PROBLEM. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.