Description of Event or Problem · 1
THE USER RECEIVED QUESTIONABLE CALCIUM RESULTS FOR SIX PATIENTS. ALL REPEAT TESTING WAS PERFORMED ON A DIFFERENT COBAS 6000 C501 MODULE (THE SERIAL NUMBER IS UNKNOWN). PATIENT 1, INITIAL RESULT WAS 5.9 MG/DL (ACCOMPANIED BY A DATA FLAG). THE SAME SAMPLE REPEATED GAVE 8.7 MG/DL. PATIENT 2, FEMALE, AGE (B)(6), INITIAL RESULT WAS 5.6 MG/DL (ACCOMPANIED BY A DATA FLAG). THE SAME SAMPLE REPEATED GAVE 7.8 MG/DL (ACCOMPANIED BY A DATA FLAG). PATIENT 3, MALE, AGE (B)(6), INITIAL RESULT WAS 7.0 MG/DL (ACCOMPANIED BY A DATA FLAG). THE SAME SAMPLE REPEATED GAVE 9.7 MG/DL. PATIENT 4, MALE, AGE (B)(6), INITIAL RESULT WAS 6.8 MG/DL (ACCOMPANIED BY A DATA FLAG). THE SAME SAMPLE REPEATED GAVE 9.6 MG/DL. PATIENT 5, MALE, AGE (B)(6), INITIAL RESULT WAS 6.5 MG/DL (ACCOMPANIED BY A DATA FLAG). THE SAME SAMPLE REPEATED GAVE 9.2 MG/DL. PATIENT 6, INITIAL RESULT WAS 5.6 MG/DL (ACCOMPANIED BY A DATA FLAG). THE SAME SAMPLE REPEATED GAVE 8.4 MG/DL (ACCOMPANIED BY A DATA FLAG). ALL THE INITIAL CALCIUM RESULTS WERE REPORTED OUTSIDE THE LABORATORY. ALL THE PATIENTS, EXCEPT PATIENT 2, WERE NOT AFFECTED BY THE INITIAL CALCIUM RESULTS. PATIENT 2 WAS AN EMERGENCY ROOM PATIENT AND WAS TREATED BASED ON THE INITIAL CALCIUM RESULT. THE USER REFUSED TO PROVIDE ANY FURTHER INFORMATION REGARDING THE PATIENT OR THE TREATMENT PROVIDED. NO ADVERSE EVENTS WERE REPORTED. THE CALCIUM REAGENT LOT NUMBER WAS 62492901. THE FIELD SERVICE REPRESENTATIVE DETERMINED A DIRTY INCUBATION BATH WAS THE CAUSE OF THE DISCREPANCIES. HE PERFORMED BATH EXCHANGES AND NATURAL CYCLING OF THE WATER WHICH CLEANED THE BATH. CALIBRATIONS AND QUALITY CONTROL WERE PERFORMED BY THE USER WHICH WERE SUCCESSFUL.