Description of Event or Problem · 1
THE CUSTOMER RECEIVED 276 QUESTIONABLE PATIENT RESULTS. THREE RESULTS FROM TWO PATIENTS WERE ERRONEOUS. THIS MODULAR CORE UNIT CONTAINS TWO ISE UNITS, THE CUSTOMER WAS UNABLE TO VERIFY WHICH ISE UNIT THE INITIAL RESULTS WERE TESTED ON. PATIENT 1, INITIAL SODIUM RESULT WAS 141 MMOL/L, SAMPLE REPEATED (B)(6) 2010, GAVE 134 MMOL/L. PATIENT 2, INITIAL SODIUM RESULT WAS 152 MMOL/L, SAMPLE REPEATED (B)(6) 2010, GAVE 131 MMOL/L. THE INITIAL POTASSIUM RESULT WAS 5.0 MMOL/L, REPEATED (B)(6) 2010 ON THE SAME ISE UNIT, GAVE 4.3 MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT HAVE INFORMATION TO DETERMINE IF THE PATIENTS WERE HARMED BY THE ERRONEOUS RESULTS. NO ADVERSE EVENTS WERE REPORTED. THE SODIUM CARTRIDGE LOT NUMBER WAS E97. THE POTASSIUM CARTRIDGE LOT NUMBERS WERE M91 AND N56. THE FIELD SERVICE REPRESENTATIVE DID NOT DETERMINE THE CAUSE OF THE DISCREPANCIES. HE REMOVED AND REINSTALLED ALL SYRINGES AND PERFORMED PERFORMANCE CHECKS.