COBAS B 221 6 ROCHE OMNI S6 SYSTEM

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). RESULTS - DEVICE SUBASSEMBLY = MEASURING CHAMBER.

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE MEASURING CHAMBER MODULE WAS PROVIDED FOR INVESTIGATION AND THE ISSUE COULD NOT BE REPRODUCED. THE CUSTOMER CHANGED THE PH ELECTRODE PRIOR TO THE FIELD SERVICE VISIT. QUALITY CONTROL DATA SUGGESTS THERE MAY HAVE BEEN A PROBLEM WITH THE PH ELECTRODE. THE LOT NUMBER OF THE ELECTRODE WAS NOT AVAILABLE. NO FURTHER INVESTIGATION COULD BE PERFORMED ON THIS ELECTRODE. IT WAS NOTED THE CUSTOMER ONLY RUNS ONE LEVEL OF QUALITY CONTROL. IT IS RECOMMENDED TO COMPLETE A QUALITY CONTROL TEST ON THREE LEVELS AFTER EACH ELECTRODE EXCHANGE, AFTER EACH EXCHANGE OF SOLUTIONS AND PACKS AND AFTER STARTUP OF THE INSTRUMENT. THE CUSTOMER DID NOT FOLLOW THE RECOMMENDED ROCHE QC CONCEPT AND RAN ONLY 1 QUALITY MATERIAL TO CHECK THE INSTRUMENT PERFORMANCE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY HAD BEEN GETTING IMPLAUSIBLE PH MEASUREMENT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. FOR EXAMPLE, THE ANALYZER WILL MEASURE PH VALUES OF 7.5 TO 7.6 FOR A SAMPLE. WHEN A SAMPLE IS MEASURED ON A DIFFERENT ANALYZER, THE PH RESULT WILL BE 7.4. DATA WAS PROVIDED FOR A TOTAL OF TWO PATIENT SAMPLES. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PLEASE REFER TO THE ATTACHMENTS FOR SAMPLE RESULTS FROM EACH PATIENT. EACH PRINTOUT ON THE ATTACHMENT REPRESENTS RESULTS FROM A DIFFERENT SAMPLE OF THE SAME PATIENT. THE SECOND PATIENT IS A (B)(6) FEMALE BORN ON (B)(6) 1939 AND WEIGHING (B)(6). THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE PH ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER IDENTIFIED THE MEASURING CHAMBER AS THE CAUSE OF THE ISSUE. HE CHANGED THE MEASURING CHAMBER. AFTER CHANGING THE CHAMBER, QUALITY CONTROL MEASUREMENTS AND COMPARATIVE MEASUREMENTS WERE CORRECT.