COULTER AC.T 5DIFF RINSE
Received Oct 7, 2011 · Event occurred Jun 11, 2008
Report 1061932-2011-01597 · MDR key 2320146
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED ERRONEOUS TEST RESULTS WERE OBTAINED FOR RED BLOOD CELL (RBC) COUNT, HEMATOCRIT (HCT) AND PLATELET (PLT) COUNT FOR TWO PTS. THERE WERE INSTRUMENT GENERATED FLAGS WITH THE TEST RESULTS. ERRONEOUS FLAGGED RESULTS WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER RERAN THE SAMPLES AND THE ABOVE MENTIONED PARAMETERS RECOVERED HIGHER. RERUNS FOR BOTH SAMPLES WERE CONSIDERED CORRECT. THE COULTER ACT 5DIFF RINSE WAS FOUND TO BE CONTAMINATED AND WAS REPLACED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
ON (B)(6) 2008, THE COULTER AC.T 5DIFF RINSE WAS REPLACED BY THE CUSTOMER AND A REPLACEMENT BOTTLE WAS PROVIDED. PRODUCT WAS RETURNED ON (B)(6) 2008. TESTING WAS PERFORMED AND THE PRODUCT WAS CONFIRMED TO BE CONTAMINATED. FIELD SERVICE WAS REQUESTED TO DECONTAMINATE THE INSTRUMENT AND CHECK SYSTEM DILUTION PERFORMANCE. THE PROBLEM WAS RESOLVED WITH THE REPLACEMENT OF THE COULTER AC.T 5DIFF RINSE REAGENT. AS OF (B)(4), 2008, THERE WERE NO FURTHER REPORTED EVENTS OF ERRONEOUS RESULTS FROM THIS ACCOUNT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.