BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGH TARGET SLIDES NORMAL METAPHASE

    MDR report key: 21701044 · Received March 26, 2025

    Report

    Report Number
    3005248192-2025-00076
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    March 20, 2025
    Report Date
    June 6, 2025
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    PPM
    UDI-DI
    00884999023512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE CGH TARGET SLIDES NORMAL METAPHASE, LIST 06J96-001, WHICH IS ALSO US FDA APPROVED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A QUALITY DATA REVIEW, RETAIN SAMPLE EVALUATION, AND A COMPLAINT HISTORY REVIEW. THE INVESTIGATION IS AS FOLLOWS: QUALITY DATA REVIEW: DEVICE HISTORY RECORD (DHR) / BATCH RECORD REVIEW: BATCH RECORDS (RELATED MANUFACTURING PROCEDURE) OBTAINED FROM ABBOTT MOLECULAR DOCUMENT CONTROL WERE REVIEWED TO IDENTIFY ANY ISSUES RELATED TO THE REPORTED COMPLAINT DURING PRODUCTION OF THE LOT NUMBER. NO ERRORS WERE IDENTIFIED. SLIDES (NORMAL MALE METAPHASE SLIDES FOR CGH (PART# 30-506010) LOT# 404656) WERE MANUFACTURED ACCORDING TO MP-30-506010 (NORMAL MALE METAPHASE SLIDES FOR CGH) REV. 004. SLIDES ARE MANUALLY MANUFACTURED. THERE WERE NO ISSUES NOTED IN MANUFACTURING AND SLIDES ARE LABELED AND INSPECTED DURING SLIDE KIT MANUFACTURING AND A 100% INSPECTION IS PERFORMED (3.0 PHASE (SLIDE) EVALUATION) WHERE DAMAGE TO A SLIDE WOULD HAVE BEEN IDENTIFIED. 180 SLIDES WERE MANUFACTURED (LOT# 404656) ON 9/10/2024 AND SAMPLES WERE SUBMITTED TO QUALITY CONTROL (QC) FOR FUNCTIONAL ASSAY PERFORMANCE WITHOUT ISSUE. KIT (CGH NORMAL METAPHASE SLIDES (2 X 5 SLIDES) (LIST# 06J96-001 / PART# 30-806010) LOT# 404655 QTY. 15 WERE MANUFACTURED ACCORDING TO MP-30-806010 (CGH NORMAL METAPHASE SLIDES (2 X 5 SLIDES) REV. 013 ON 10/22/2024. MANUFACTURING OF THE KITS IS A MANUAL PROCESS, AND 100% IN-PROCESS INSPECTION IS PERFORMED BY MANUFACTURING PERSONNEL AND DOCUMENTED ACCORDING TO MP-09-153 (MANUAL KIT PACK PROCEDURE) REV. 006. MANUAL KIT PACK PROCEDURE AND NO SLIDE DAMAGE AND/OR BROKEN WAS IDENTIFIED. FOLLOWING MANUFACTURING, KITS WERE INSPECTED (QTY. 15) BY QUALITY CONTROL AND INSPECTED AGAIN FOR ANY PHYSICAL DEFECTS AND DOCUMENTED. MATERIAL WAS INSPECTED, AND NO PHYSICAL DEFECTS WERE NOTED. MATERIAL WAS INSPECTED AT SLIDES AND KIT MANUFACTURING WITH NO NOTED ISSUES OF PHYSICAL INTEGRITY. NO PRODUCT DEFICIENCY WAS IDENTIFIED AS A RESULT OF THIS REVIEW. CAPA / NON-CONFORMANCE REVIEW: A SEARCH OF NC/CAPA RECORDS WAS PERFORMED FOR ANY INSTANCES OF AN INJURY SUSTAINED WHILE CLEANING THE WASTE CHUTE ON AN ALINITY M SYSTEM. THE QUERY DID NOT IDENTIFY ANY QUALITY RECORDS RELATED TO THE REPORTED COMPLAINT. CUSTOMER IMAGE REVIEW: THE CUSTOMER PROVIDED 4 IMAGES. ALL FOUR IMAGES SHOW AND VERIFY THE IDENTITY OF THE SLIDE NORMAL MALE METAPHASE SLIDES FOR CGH (PART# 30-506010) LOT# 404656 CONTAINED WITHIN KIT CGH NORMAL METAPHASE SLIDES (2 X 5 SLIDES) (LIST# 06J96-001 / PART# 30-806010) LOT# 404655.THE PICTURES DETAIL A CRACKED SLIDE AS REPORTED BY THE CUSTOMER. THE IMAGES SUPPORT THE CUSTOMER'S REPORT OF A DAMAGED/BROKEN SLIDE; HOWEVER, THE REPORT OF THIS EVENT WAS REPORTED POST SHIPPING AND HANDLING. THE EVENT APPEARS ISOLATED AND DOES NOT SUGGEST A PRODUCT DEFICIENCY. RETAIN SAMPLE EVALUATION: EVALUATION OF THE FILE SAMPLES (QTY.1 KIT) FOR CGH NORMAL METAPHASE SLIDES (2 X 5 SLIDES) (LIST# 06J96-001 / PART# 30-806010) LOT# 404655 (CONTAINING INDIVIDUAL SLIDES NORMAL MALE METAPHASE SLIDES FOR CGH (PART# 30-506010) LOT# 404656) QTY. 10 WERE VISUALLY INSPECTED FOR DAMAGED AND/OR BROKEN SLIDES. INSPECTION USED MANUFACTURING PROCEDURE (MP) MP-30-806010 (CGH NORMAL METAPHASE SLIDES (2 X 5 SLIDES)) REV. 013 CONTAINING MP-09-153 (MANUAL KIT PACK PROCEDURE) REV. 006 AND MP09-153-F01 (MANUAL KIT PACK INSPECTION) REV. 006 AS GUIDANCE FOR VISUAL INSPECTION. NO PHYSICAL DAMAGED OR BROKEN SLIDES WERE IDENTIFIED AS A RESULT OF THE INSPECTION. COMPLAINT HISTORY REVIEW: A COMPLAINT SEARCH WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THAT BEING INVESTIGATED. NO ADDITIONAL RELATED COMPLAINTS WERE IDENTIFIED. COMPLAINT TRENDING WAS REVIEWED. THE UPPER CONTROL LIMIT WAS NOT EXCEEDED, AND NO ADVERSE TREND WAS IDENTIFIED FOR THE CGH TARGET SLIDES NORMAL METAPHASE, LIST 06J96-001. BASED ON THE RESULTS OF THE INVESTIGATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE CGH TARGET SLIDES NORMAL METAPHASE, LIST 06J96-001.

    Additional Manufacturer Narrative · 0

    CORRECTION TO CAPA / NON-CONFORMANCE REVIEW: CAPA / NON-CONFORMANCE REVIEW: A SEARCH OF NC/CAPA RECORDS WAS PERFORMED FOR ANY INSTANCES OF AN INJURY SUSTAINED FROM BROKEN SLIDES. THE QUERY DID NOT IDENTIFY ANY QUALITY RECORDS RELATED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RECEIVING ONE BROKEN SLIDE IN THEIR ORDER OF CGH TARGET SLIDES NORMAL METAPHASE SLIDES. THE CUSTOMER WAS WEARING LATEX GLOVES AND NO ONE WAS INJURED. THE SLIDES WERE REPLACED WITH A NEW LOT. THERE WAS NO PATIENT INVOLVED AS THE BROKEN SLIDE WAS IDENTIFIED BY THE USER PRIOR TO USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2416931 CGH TARGET SLIDES NORMAL METAPHASE GENERAL PURPOSE REAGENT PPM ABBOTT MOLECULAR, INC. 404655 00884999023512

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown