THE PROBECHEK HER-2/NEU CONTROL SLIDES ARE PREPARED FROM CULTURED HUMAN CELL LINES. THE CELLS ARE HARVESTED, FIXED IN SUSPENSION MEDIUM, PARAFFIN-EMBEDDED, AND APPLIED TO GLASS MICROSCOPE SLIDES. THE PROCEDURES USED TO HARVEST THE CELLS AND PREPARE THE SLIDES ARE OPTIMIZED FOR PRODUCTION OF SLIDES FOR INTERPHASE FISH. CUSTOMER RECEIVED ONE BOX OF THE PROBECHEK SLIDES OPEN AND SOME OF THE SLIDES HAD SLID OUT OF BOX DURING SHIPMENT AND CRACKED. THERE WAS NO DAMAGE TO THE OUTSIDE OF SHIPPING CARTON OBSERVED; ONLY THE SLIDES WERE DAMAGED. CUSTOMER DISCARDED AFFECTED BOX OF SLIDES. PER PROBECHEK, CONTROL SLIDES FOR FLUORESCENCE IN SITU HYBRIDIZATION (FISH)* USING PATHVYSION, HER-2 DNA PROBE KIT (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 INJURY WAS REPORTED.
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Patient 1
INSPECTION FROM QC RETENTION SAMPLE FROM THE LOT IN QUESTION IDENTIFIED NO DAMAGED (CRACKED/BROKEN) SLIDES. 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.
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Patient 1
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).