inforMED
MalfunctionKSO

MTS 24 PLACE CENTRIFUGE

Received Apr 1, 2008 · Event occurred Mar 10, 2008

Report 1056600-2008-00105 · MDR key 1022660

Device

Generic name

Centrifuge

Model number

NA

Catalog number

MT515060

Lot number

NA

Product problems

  • Nonstandard Device

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE MTS 24 PLACE CENTRIFUGE WAS NOT IN SPECIFICATION. THE USER DETECTED THE ISSUE AND RETESTED USING AN ALTERNATE CENTRIFUGE PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED. INCORRECT CENTRIFUGATION SPEED OR TIME DURING TESTING, IF UNDETECTED, MAY LEAD TO ERRONEOUS TEST RESULTS.

Additional Manufacturer Narrative

NO DEFINITIVE ROOT CAUSE WAS DETERMINED. THE CENTRIFUGE WAS OUT OF WARRANTY. THE CUSTOMER'S BIO MED TECH WAS INSTRUCTED TO CHECK THE GEL CARDHOLDERS FOR FREE MOVEMENT. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS INSTRUMENT SINCE THIS INCIDENT.