OMNI

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. AN INSTRUMENT OR ELECTRODE RELATED ISSUE WAS NOT IDENTIFIED. THE INVESTIGATION NOTED THAT THE CUSTOMER ONLY RAN 1 LEVEL OF QUALITY CONTROLS INSTEAD OF THE RECOMMENDED 2 LEVELS WITHIN 24 HOURS. THE CUSTOMER REPLACED THE HEPARINIZED TUBES AND NO FURTHER ISSUES OCCURRED AFTERWARDS. BASED ON THE AVAILABLE DATA, THE POSSIBLE ROOT CAUSES MAY BE THAT THERE WAS A LOW CONCENTRATION OF ICA IN THE SAMPLES OR PRE-ANALYTIC ISSUES CAUSED THE LOW RESULTS.

Additional Manufacturer Narrative

PATIENT 1 WEIGHT WAS PROVIDED AS (B)(6); THE UNIT OF MEASURE WAS NOT PROVIDED. PATIENT 2 IS A MALE WITH A DATE OF BIRTH OF (B)(6). PATIENT 2 WEIGHT WAS PROVIDED AS (B)(6); THE UNIT OF MEASURE WAS NOT PROVIDED. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE TEST BEING REPORTED IS IONIZED CALCIUM (ICA).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR 4 SAMPLES FROM NEWBORN PATIENTS TESTED FOR CALCIUM (CA) ON A B221 ANALYZER. IT WAS NOTED THAT 4 NEWBORN PATIENTS WERE TESTED FOR CA AND THE RESULTS WERE BELOW 0.5 MMOL/L AFTER CHANGING THE ELECTRODES. OF THE DATA PROVIDED, 2 PATIENT SAMPLES WERE ERRONEOUS. PATIENT 1 INITIAL CA RESULT WAS 0.403 MMOL/L. THE PATIENT WAS JITTERY. THE PATIENT'S CALCIUM INJECTIONS WERE MAINTAINED. THE CA TEST WAS REPEATED 3 TIMES ON THE B221 ANALYZER WITH RESULTS OF 0.419 MMOL/L, 0.360 MMOL/L AND 0.376 MMOL/L. PATIENT 2 INITIAL CA RESULT WAS 0.240 MMOL/L. THIS RESULT WAS CONSIDERED TO BE LOW. THE CA TEST WAS REPEATED 3 TIMES ON THE B221 ANALYZER WITH RESULTS OF 0.240 MMOL/L, 0.236 MMOL/L AND 0.225 MMOL/L. THE CLINICIANS DOUBTED THE RESULTS FROM THE B221 ANALYZER SINCE PATIENT 1 HAD BEEN MAINTAINED ON THE MAXIMUM DOSE OF CALCIUM INJECTIONS AND BOTH PATIENTS WERE CLINICALLY FREE ON D2. BASED ON THIS, SERUM SAMPLES WERE OBTAINED FROM BOTH PATIENTS WHERE PATIENT 1 HAD A CA RESULT OF 1.574 MMOL/L AND PATIENT 2 HAD A CA RESULT OF 1.548 MMOL/L. NO ADVERSE EVENTS WERE REPORTED. THE CA ELECTRODE LOT NUMBER AND EXPIRATION DATE WAS NOT PROVIDED. IT WAS NOTED THAT QUALITY CONTROLS WERE ACCEPTABLE AFTER CHANGING ELECTRODES.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).