inforMED
MalfunctionGQH

CMV IGM CAPTURE

Received Apr 12, 2006 · Event occurred Mar 20, 2006

Report 714338 · MDR key 714338

Device

Generic name

Test Kit, Antigen

Model number

*

Catalog number

720-330

Lot number

90505Z

Product problems

  • False Positive Result
  • Replace

Patient

*

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

Narrative

Description of Event or Problem

DIAMEDIX CHANGED THE ANTIGEN (CMV) USED IN THE TEST KITS PURCHASED BY THE HOSPITAL LABORATORY FOR PERFORMING CMVIGM TESTING. A NOTE WAS PROVIDED IN THE KIT TO ANNOUNCE THE PRODUCT CHANGE AND TO SAY THAT PERFORMANCE SHOULD NOT BE AFFECTED. PRIOR TO THIS CHANGE, THE LABORATORY EXPERIENCED 1 POSITIVE CMVIGM PER EVERY 3 TEST RUNS AND 1 EQUIVOCAL PER EVERY 5 TEST RUNS. AFTER THE CHANGE, THE LAB BEGAN TO SEE A HIGHER INCIDENCE OF POSITIVE RESULTS (1 PER RUN) AND EQUIVOCAL RESULTS (2 PER RUN). TECH SERVICES AT DIAMEDIX HAS BEEN CONTACTED AND THE RAW DATA HAS BEEN FAXED TO THEM. A PARTIALLY USED TEST KIT WAS ALSO RETURNED ALONG WITH SOME BLIND SAMPLES FOR THEM TO USE WITH THE PARTIALLY USED KIT. ALL SAMPLES WITH POSITIVE AND EQUIVOCAL TEST RESULTS ARE BEING SENT TO AN OFF SITE REFERENCE LAB FOR CONFIRMATION UNTIL THIS SITUATION IS RESOLVED.