BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEGLOBAL MEDIA

    MDR report key: 19209743 · Received April 29, 2024

    Report

    Report Number
    1222779-2024-00002
    Event Type
    Injury
    Date Received
    April 29, 2024
    Date of Event
    March 2, 2024
    Report Date
    June 26, 2024
    Manufacturer
    LIFEGLOBAL GROUP, LLC
    Product Code
    MQL
    PMA / PMN Number
    K053552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORD REVIEW: ALL THE DH RS RELATED TO THE LGGG RECALL THE FOLLOWING DHRS WERE REVIEWED: PRODUCT LGGG-020 LOT: 231020-018741 AND SUBASSEMBLIES (86050020 LOT: 23I020-018745 AND 8605 LOT: 231020-018744), LGGG-050 LOT 231020-0 18742 (86050050 LOT: 231020-018746 AND, 8605 LOT: 231020- 0 I 8744) AND LGGG-100 LOT 231020-018743 (86050 I 00 LOT: 231020-018747 AND 8605 LOT: 231020-0 I 8744) WERE REVIEWED AND RELATED NCMR-2023-11-00015 TO THE PROBLEM REPORTED IN THIS COMPLAINT. THE NCMR WAS RELATED TO A FAILURE OF THE MEA EMBRYONIC GROWTH AND DEVELOPMENT TEST; HOWEVER, MEA EG&D IS NOT A TEST REQUIRED AS A RELEASE REQUIREMENT. THE MEA EG&D IS A TEST THAT SOTIS THE EMB1YOS THAT DEVELOP AFTER INCUBATION IN THE TEST ARTICLE AND DOES NOT EVALUATE THE FUNCTIONALITY OF THE MEDIUM LIKE THE REGULAR MEA TEST PERFORMED ON THE TEST ARTICLE, WHICH PASSED THE TEST WITH NO PROBLEMS. FOR THAT REASON, THE PRODUCT WAS RELEASED USING THE RESULTS OF THE REGULAR MEA TEST. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: SAMPLES FROM THE SAME LOT NUMBER WERE INSPECTED AND AS RESULT THE COLOR APPEARANCE WERE AS EXPECTED. FUNCTIONAL EVALUATION: RETENTION SAMPLES FROM THE SAME LOT NUMBER WERE TESTED. THE MEA TEST AND PH TEST PERFORMED PASSED; HOWEVER, THE MEA EG&D TEST REQUESTED AS ADDITIONAL INFORMATION, FAILED. MOREOVER, SAMPLES RECEIVED FROM DISTRIBUTION CENTER WERE TESTED. STERILITY TEST, PH, OSMOLALITY, LAL ENDOTOXIN, GENTAMICIN AND HSA CONCENTRATION, WERE PERFORMED, AND ALL PASSED ACCORDING TO SPECIFICATIONS. PLEASE REFER TO THE QC TEST RESULTS OF THE DC SAMPLES ATTACHED TO THIS INVESTIGATION REPORT. SAMPLES RETURNED FROM CUSTOMER, RELATED TO THE SAME COMPLAINT LOT WERE TESTED AND FAILED THE MEA EG&D TEST. AS PART OF CAP A INVESTIGATION AND SINCE THE MEA EG&D FAIL , ADDITIONAL CHEMICAL TESTS WERE PERFORMED (POTASSIUM PHOSPHATE AND MAGNESIUM SULFATE) AND THE RESULTS DETERMINED AN ABSENT OF THE MAGNESIUM COMPONENT AND DOUBLE CONCENTRATION OF POTASSIUM PHOSPHATE. ROOT CAUSE ANALISYS: BASED ON THE COMPLAINT DETAILS RECORDED IN THE REPORT, IT WAS DETERMINED THROUGH OUR FPP TEAM THAT THIS PRODUCT AND LOT WAS ASSOCIATED TO THE LGGG IVF MEDIA RECALL. TO DETERMINATE THE POSSIBLE ROOT CAUSES THE A CAPA WAS OPENED. AT THE END OF THE INVESTIGATION PROCESS IT WAS DETERMINATE THAT THE POTENTIAL ROOT CAUSES WERE: 1. MATERIAL : CONTAINERS FOR STORING THE RAW MATERIAL (MAGNESIUM SULFATE AND POTASSIUM PHOSPHATE) ARE IDENTICAL IN COLOR & SHAPE. 2. METHOD: CURRENT PROCESS LACKS MEASURES TO PREVENT POTENTIAL CONFIRMATION BIAS MIX UPS WITHIN THE WEIGHING STEPS AND ADDITION OF RAW MATERIAL DURING THE FORMULATION OF THE MEDIA PRODUCT. ADDITIONALLY, AS CONTRIBUTE FACTOR IS DETERMINATE THAT THE TESTING PACKAGE WAS DESIGNED WITH THE SPECIFIC TESTING ACCORDING TO THE PRODUCT REQUIREMENTS, THAT WAS NOT CAPABLE OF DETECTING MISSING CRITICAL COMPONENTS SUCH AS MAGNESIUM SULFATE IN THE PRODUCT. THE ALLEGATIONS OF THIS COMPLAINT COULD NOT BE CONFIRMED. CORRECTIVE ACTION PLAN WILL BE HANDLED THROUGH THE CAPA. PREVENTATIVE ACTIONS BEING TAKEN: 1. IMPLEMENT A BARCODE SCANNING TECHNOLOGY TO REDUCE THE OPPORTUNITY FOR ERRORS IN THE WEIGHTING AND FORMULATION PROCESSES. CORRECTIVE ACTIONS BEING TAKEN: 1. PROCEDURE CHANGE TO ADD VISUAL VERIFICATION FROM SECOND STAFF MEMBER. VERIFICATION OF CLEAR LABELING AND SEPARATION OF INGREDIENTS DURING FORMULATION PROCESS. 2. IMPLEMENTATION OF ANALYTICAL TECHNIQUES TO IDENTIFY PRESENCE OF MAGNESIUM CONTENT WITHIN THE BULK MEDIA AFTER FORMULATION. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Additional Manufacturer Narrative · 0

    D4: MODEL #: LGGG-020 OR LGGG-050 OR LGGG-100. LOT #: 231020-0187421 OR 231020-018742 OR 231020-018743. UDI#: (B)(4). G2: FOREIGN: CANADA. H7: RECALL # 1216677-11-30-2023-001-R EVENT ID # (B)(4). DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IDENTIFIED THROUGH THE FERTILITY PATIENT PROGRAM (FPP) AS USING LGGG IVF PRODUCT. THE PATIENT WAS 21 WEEKS 5 DAYS PREGNANT ON (B)(6) 2024, WITH A FETUS IDENTIFIED ON ULTRASOUND AS HAVING TRANSPOSITION OF THE GREAT ARTERIES. THE COUPLE REPORTEDLY DOES NOT HAVE PERSONAL OR FAMILY HISTORY OF CARDIAC DEFECTS. NO ADDITIONAL INFORMATION IS AVAILABLE. 1222779-2024-0000002 LGGG 2024-04-0000020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030016 LIFEGLOBAL MEDIA IVF MEDIA MQL LIFEGLOBAL GROUP, LLC SEE H11 SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Congenital Anomaly