PHOS2

Additional Manufacturer Narrative

THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. A GENERAL REAGENT ISSUE COULD BE EXCLUDED, AS THE GLOBAL LOT PERFORMANCE WAS INCONSPICUOUS. A LOCAL ISSUE WITH THE REAGENT LOT WAS FEASIBLE, WITH POSSIBLE CONTRIBUTING FACTORS SUCH AS SHIPPING/STORAGE/HANDLING/ALTERED INSTRUMENT CONDITION.

Additional Manufacturer Narrative

THE COBAS 6000 C501 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE PHOS2 RESULTS FROM THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 1.2 MMOL/L AND THE REPEAT RESULT WAS 1.57 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.