COBAS B 101 HBA1C TEST

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER HAD NOTICED A SQUEAKY RUBBING SOUND THAT BECAME LOUDER THAN NORMAL ON THE INSTRUMENT. THE CUSTOMER ALSO NOTED THAT THE TEMPERATURE ERROR WAS DISPLAYED WHEN THE INSTRUMENT WAS USED CONTINUOUSLY. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE CUSTOMER PURCHASED A NEW B101 INSTRUMENT AND DECLINED TO SEND ANY PRODUCT BACK. NO FURTHER INVESTIGATION IS REQUESTED BY THE CUSTOMER. MANUFACTURER BATCH RECORD FOR COBAS B101 HBA1C TEST DISC LOT 824041-01 SHOWED NO ABNORMALITIES. 10 WHOLE BLOOD "LOW" SAMPLES WERE TESTED WITH DISCS' RETENTION MATERIAL HBA1C LOT 824041-01 WITH A RETENTION COBAS B101 INSTRUMENT. 10 WHOLE BLOOD "MIDDLE" SAMPLES WERE TESTED WITH DISCS' RETENTION MATERIAL HBA1C LOT 824041-01 WITH A RETENTION COBAS B101 INSTRUMENT. 10 WHOLE BLOOD "HIGH" SAMPLES WERE TESTED WITH DISCS' RETENTION MATERIAL HBA1C LOT 824041-01 WITH A RETENTION COBAS B101 INSTRUMENT. THE INVESTIGATION DID NOT SEE ANY DISCREPANT HBA1C RESULTS MEASURED WITH RETENTION MATERIAL HBA1C DISC LOT 824041-01. THE CUSTOMER'S LOW HBA1C RESULTS COULD NOT BE REPRODUCED. ALL OBTAINED RESULTS WERE ACCEPTABLE AND MEET THE SPECIFICATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR HBA1C ON A COBAS B 101 INSTRUMENT. THE SPECIFIC DATE OF EVENT IS NOT KNOWN. THE RESULT FROM THE B101 INSTRUMENT WAS 5.3%. THE RESULT FROM AN OUTSOURCED LABORATORY WAS 6.8%. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE B 101 INSTRUMENT SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

THE INITIAL REPORT STATED: "THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION." THIS SHOULD SAY: "THE METER AND REAGENT DISKS WERE REQUESTED FOR INVESTIGATION."