Description of Event or Problem · 1
FACILITY CURRENTLY USES THE COAGUCHECK PRO DM DEVICE BY ROCHE TO MANAGE ITS PTS ON COUMADIN AND HAS DONE SO SINCE 1996. THE COAGUCHECK PRO PTN CARTRIDGES FROM ROCHE WERE FOUND TO BE DEFECTIVE FOLLOWING USE OF NEW LOT # 20119001 DURING 11/5/01 TO 11/14/01. THE CLINICAL PHARMACIST BECAME SUSPICIOUS FOLLOWING MANY ABNORMALLY HIGH INR VALUES IN PTS WHO WERE CONSISTENTLY STABLE. PTS WERE SUBSEQUENTLY SENT TO THE HOSP LAB FOR CONFIRMATION INR VALUES MOST OF WHICH WERE NOT CONSISTENT WITH THE INR READINGS ON THE COAGUCHECK PRO DM DEVICES. THIS REQUIRED THE FACILITY'S COUMADIN CLINIC TO CALL APPROX 300 PTS WHO HAD BEEN TESTED ON THE DEFECTIVE CARTRIDGES AND HAVE THEM RETURN TO LAB FOR RE-CHECK OF THE INR. MOST PTS REQUIRED RE-ADJUSTMENT OF THEIR COUMADIN DOSE TO MAINTAIN THEM WITHIN THE THERAPEUTIC INR RANGE. THE TREND SEEN WITH THE DEFECTIVE CARTRIDGES WAS BIASED TOWARDS THE HIGH-END. THUS, MANY PTS WHO WERE THOUGHT TO BE WITHIN THE THERAPEUTIC RANGE, WERE ACTUALLY FOUND TO BE SUBTHERAPEUTIC ON LAB RECHECK. FURTHERMORE, MANY PTS WHO WERE INITIALLY THOUGHT TO BESUPRATHERAPEUTIC AND HAD THEIR COUMADIN DOSE DECREASED WERE ACTUALY FOUND TO BE SUBTHERAPEUTIC ON RECHECK IN THE LAB. ROCHE DID NOT ACT IN AN EXPEDIOUS AND PROFESSIONAL MANNER IN HANDLING CASE. IN FACT, ROCHE REP ADVISED THAT OTHER MEDICAL FACILITIES WERE REPORTING THE SAME PROBLEMS WITH THAT SPECIFIC LOT NUMBER, BUT ROCHE AS OF TODAY, STILL HAS FAILED TO MAKE AN OFFICIAL STATEMENT NOR WOULD THEY AT FACILITY'S REQUEST. FACILITY BELIEVES THIS TO BE UNETHICAL.