MalfunctionLJC

VIDAS 30 IMMUNOASSAY ANALYZER

Received Jul 16, 1996

Report MW1009502 · MDR key 34172

Device

Generic name

Immunoassay Analyzer

Manufacturer

Biomerieux Vitek, Inc.

Product problems

Foreign material
Obstruction of Flow

Patient

NO INFO

Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

ON 7/5/95, A FIELD REP FROM THE MFR DISCOVERED AN INTERMITTENT PARTIAL OBSTRUCTION OF ONE (1) CHANNEL OF THE INSTRUMENT ASSEMBLY DUE TO A PORTION OF A SOLID PHASE PIPETTE CAP COVER. THIS IS A UNIQUE FAILURE THAT COULD NOT BE DETECTED BY STANDARD QUALITY CONTROL PROCEDURES RECOMMENDED BY THE MFR AND USUALLY PERFORMED BY THE INSTITUTION. THE END RESULT OF THE INSTRUMENT FAILURE WAS SEVENTEEN (17) POSSIBLE FALSE POSITIVE TEST RESULTS FOR CHLAMYDIA TRACHOMATIS COVERING THE TIME PERIOD FROM 5/12/96 TO 7/7/96. APPROPRIATE STEPS ARE BEING TAKEN TO NOTIFY THE PTS AND THEIR PHYSICIANS.