2795 SEPARATIONS MODULE

Additional Manufacturer Narrative

CONCLUSIONS - THE CUSTOMER REPORTED THAT THEY REPLACED A WET AND LEAKING SYRINGE ON THE INSTRUMENT. THIS CUSTOMER HAD ALSO REPORTED LOW INTERNAL STANDARD INJECTION RESPONSE ON THE INSTRUMENT. WHEN THE WATERS SERVICE ENGINEER ARRIVED AT THE LAB TO INVESTIGATE THE ISSUE, HE COULD NOT DUPLICATE THE LOW INTERNAL STANDARD INJECTION RESPONSE. IT IS POSSIBLE THAT THE WET AND LEAKING SYRINGE COULD RESULT IN INCONSISTENT VOLUME THAT MAY AFFECT INTERNAL STANDARD RESPONSE. REPLACEMENT OF THE SYRINGE APPEARS TO HAVE CORRECTED THE ISSUE. WATERS WILL FILE A SUPPLEMENTAL REPORT IF ADD'L INFO BECOMES AVAILABLE.

Description of Event or Problem

THIS DIAGNOSTIC LABORATORY CUSTOMER REPORTED TWO INSTANCES OF LOW INTERNAL STANDARD INJECTION RESPONSE THAT AFFECTED TWO REPORTED PT RESULTS. IN THE FIRST CASE, WHEN THE LAB IDENTIFIED THE ERROR, THE TEST WAS REPEATED. SINCE THE DIFFERENCE IN THE REPORTED TEST RESULT WAS WITHIN THE THERAPEUTIC RANGE FOR THE REPORTED RESULT, IT WAS NOT CORRECTED. IN THE SECOND CASE, THE LAB REPORTED THAT THE INACCURATE RESULT WAS FOUND WEEKS LATER. THERE WAS NO PHYSICIAN REQUEST FOR A REPEAT TEST. THEREFORE, THE LAB DID NOT TAKE ANY FURTHER ACTION. THE SAMPLE HAS SUBSEQUENTLY BEEN DISCARDED. ATTEMPTS TO GAIN INFO ON ANY PT IMPACT IN THIS CASE HAVE BEEN UNSUCCESSFUL.