ELECSYS CK-MB

Additional Manufacturer Narrative

SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND THE CUSTOMER'S RESULTS WERE REPRODUCED.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE CK-MB ELECSYS E2G RESULT FROM AN UNKNOWN ROCHE ANALYZER. THERE WAS AN ALLEGATION THAT MACRO-CK WAS INTERMITTENTLY DETECTED. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

SAMPLE FROM THE PATIENT WAS INVESTIGATED FURTHER. THE SAMPLE WAS TREATED WITH HETEROPHILIC BLOCKING TUBE (HBT) WITH SCANTIBODIES. NO HETEROPHILIC ANTIBODIES WERE IDENTIFIED IN THE SAMPLE. THE CUSTOMER'S RESULTS WERE REPRODUCED. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE INVESTIGATION TESTED THE PATIENT SAMPLE FOR ELECSYS TSH TO RULE OUT A GENERAL ELECSYS INTERFERENCE. THE TSH RESULT INDICATED THAT THE PATIENT HAS NO KNOWN THYROID DISEASE. THEREFORE, A GENERAL ELECSYS INTERFERENCE CAN BE RULED OUT. THE INVESTIGATION PERFORMED SERUM FRACTIONATION BY (B)(6). THERE WAS NO IGG OR IGM INTERFERENCE DETECTED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.