PROBECHEK UROVYSION CONTROL SLIDES
Received Sep 8, 2010 · Event occurred May 5, 2010
Report 3005248192-2010-00003 · MDR key 1828130
Device
Generic name
Microscopic Control Slides Used In Fish Testing
Manufacturer
Abbott Molecular, Inc.Catalog number
02J27-011 (30-805070)
Lot number
422286
Product problems
- Break
- Device Packaging Compromised
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE PROBECHEK UROVYSION CONTROL SLIDES ARE NON-HYBRIDIZED SLIDES PREPARED WITH CULTURED NORMAL MALE LYMPHOBLAST CELLS AND CULTURED BLADDER CANCER CELL LINES. EACH CONTROL SLIDE CONSISTS OF TWO SEPARATE TARGET AREAS IN WHICH EACH OF THE DIFFERENT CELL TYPES HAVE BEEN APPLIED. THE CELL LINES ARE HARVESTED, FIXED IN SUSPENSION MEDIUM AND APPLIED TO THE GLASS MICROSCOPE SLIDES IN A METHOD OPTIMAL FOR FISH ( FLUORESCENCE IN SITU HYBRIDIZATION). A CUSTOMER COMPLAINT THAT 3 OF 15 PROBECHEK UROVYSION CONTROL SLIDE KITS (B)(4) LOT# 422286 CONTAINED BROKEN SLIDES UPON RECEIPT. CUSTOMER STATED THAT THERE WAS NO OBVIOUS DAMAGE TO THE OUTER PACKAGING. EACH KIT LOT 422286 CONTAINS 3 SLIDES EACH, (B)(4) LOT 421700. PER PROBECHEK CONTROL SLIDES FOR FLUORESCENCE IN SITU HYBRIDIZATION (FISH) USING UROVYSION BLADDER CANCER KIT PACKAGE INSERT (B)(4): "THE PROBECHEK CONTROLS AND ALL OTHER FRESH OR FIXED SPECIMENS SHOULD BE HANDLED AS IF CAPABLE OF TRANSMITTING INFECTIOUS AGENTS. DISPOSE OF WITH PROPER PRECAUTIONS. BECAUSE IT IS OFTEN IMPOSSIBLE TO KNOW WHICH MIGHT BE INFECTIOUS, ALL SPECIMENS ARE TO BE TREATED WITH UNIVERSAL PRECAUTIONS." NO HARM OR INJURIES OCCURRED TO THE CUSTOMER.
Additional Manufacturer Narrative
VISUAL INSPECTION OF THE CUSTOMER'S RETURNS IDENTIFIED NO DAMAGE TO THE PLASTIC SLIDE BOXES; HOWEVER, BROKEN SLIDES WERE NOTED INSIDE THE BOXES AS FOLLOWS: IN BOX #1 AND BOX #2, 1 OF 3 SLIDES WAS BROKEN IN EACH BOX; IN BOX #3, ALL 3 SLIDES WERE BROKEN. INSPECTION FROM QC RETENTION SAMPLE FROM THE LOT IN QUESTION DID NOT IDENTIFY ANY ISSUES. NO RELATED COMPLAINTS OR CAPA WERE IDENTIFIED FOR THIS MATERIAL. BASED ON THE OVERALL INVESTIGATION, THE INCIDENT APPEARS TO BE AN ISOLATED INCIDENT THAT MAY HAVE OCCURRED IN TRANSIT OF THE MATERIAL TO THE CUSTOMER SITE. NO PRODUCT DEFICIENCY HAS BEEN IDENTIFIED TO DATE.
Additional Manufacturer Narrative
ON (B)(6), 2012, THROUGH AN INTERNAL AUDIT INVESTIGATION IT WAS DISCOVERED THAT SOME DATES INCLUDED IN THE ORIGINAL MDR REPORT WERE MISSING OR INCORRECT. THE PURPOSE OF THIS MDR FOLLOW-UP REPORT #1 IS TO UPDATE THE MISSING OR INCORRECT DATES AS FOLLOWS:(B)(4).