INVESTIGATION IS IN PROCESS. COMMON DEVICE NAME INCLUDES GENERAL PURPOSE REAGENT, PRODUCT CODE: PPM. HOWEVER, THE PRODUCT CODE PPM RESULTED IN AN ERROR CODE (INVALID CODE) BY THE FDA E-SUBMITTER SOFTWARE IN THE DEVICE PRODUCT CODE SECTION. AS A RESULT PRODUCT CODE LDT, REAGENT, GENERAL PURPOSE, CLASS I, PATHOLOGY, (B)(4) - GENERAL PURPOSE REAGENT WAS USED IN E-SUBMITTER. PROBECHEK MULTIVYSION CONTROL SLIDES (LIST NUMBER 05J07-001) IS REGISTERED AND LISTED AS A GENERAL PURPOSE REAGENT WITH A PRODUCT CODE PPM, DEVICE CLASS 1 AND REGULATION NUMBER (B)(4).
D
Patient 1
(B)(4) DISTRIBUTOR RECEIVED 2 BOXES OF PROBECHEK MULTIVYSION CONTROL SLIDES THAT HAD BROKEN SLIDES IN IT. THERE WAS NO REPORT OF INJURY. THE CERTIFICATE OF ANALYSIS FOR PROBECHEK MULTIVYSION CONTROL SLIDES INDICATES THESE SLIDES CONTAIN HUMAN SOURCED AND/OR POTENTIALLY INFECTIOUS COMPONENTS. IF THIS EVENT WERE TO RECUR, IT IS POSSIBLE CUSTOMERS COULD CUT THEMSELVES WITH A POTENTIALLY INFECTIOUS SLIDE.
N
Patient 1
SUMMARY OF COMPLAINT INVESTIGATION FOR MDR 3005248192-2016-00006 FOLLOW-UP REPORT 1: INVESTIGATION INTO THIS COMPLAINT INCLUDED AN EVALUATION OF THE QUALITY DATA REVIEW, COMPLAINT HISTORY REVIEW, AND RETAIN SAMPLE EVALUATION. QUALITY DATA REVIEW : DEVICE HISTORY RECORD / BATCH RECORD REVIEW: NO ERRORS/ ISSUES WERE IDENTIFIED. THE MANUFACTURING PROCESS IS A MANUAL PROCESS. SLIDES ARE 100% INSPECTED AT THE KIT MANUFACTURING STAGE FOR SPECIFIC ISSUES INCLUDING DAMAGE. ONCE PLACED INTO KITS, THE KITS ARE SAMPLED AND INSPECTED BY QUALITY CONTROL (QC). NO ISSUES WERE NOTED DURING INSPECTION. IN ADDITION, A PROCESS IS IN PLACE TO MINIMIZE DAMAGE DURING SHIPMENT OF SLIDES. COMPLAINT HISTORY REVIEW: ASIDE FROM THE COMPLAINT CURRENTLY BEING ADDRESSED BY THIS INVESTIGATION, THREE ADDITIONAL COMPLAINTS REPORTING BROKEN/DAMAGED SLIDES WAS REPORTED IN THE LAST 12 MONTHS. (B)(4), WHICH INDICATES THAT THE ISSUE MAY BE SEEN WITH A FREQUENCY OF "OCCASIONAL." RETAIN AND / OR FILE SAMPLE EVALUATION: CUSTOMER SAMPLES WERE NOT AVAILABLE FOR INVESTIGATION. A VISUAL INSPECTION USING AM RETAIN SAMPLES FROM THE SAME LOT OF MATERIAL IN QUESTION WAS PERFORMED TO DETERMINE IF PRODUCTS HAD ANY VISUALLY IDENTIFIABLE DAMAGE. NO DAMAGE WAS IDENTIFIED. PRODUCT DEFICIENCY DECISION: BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT OR SYSTEMIC DEFICIENCY FOR PROBECHEK MULTIVYSION CONTROL SLIDES HAS NOT BEEN IDENTIFIED.