BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEUVYSION MULTICOLOR DNA PROBE KIT

    MDR report key: 14690649 · Received June 14, 2022

    Report

    Report Number
    3005248192-2022-00683
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    March 1, 2022
    Report Date
    September 9, 2022
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OYU
    UDI-DI
    00884999011694
    PMA / PMN Number
    K010288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED. NOTE: LOT, EXPIRATION, AND MANUFACTURE DATE HAVE BEEN LEFT BLANK AS THEY ARE UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: NOTE: THERE ARE THREE LIST NUMBERS FOR THE ANEUVYSION MULTICOLOR DNA PROBE KIT (A 10 ASSAY KIT, 30 ASSAY KIT, AND 50 ASSAY KIT). LIST NUMBER 05J38-10 WAS ENTERED AS THE CATALOG # IN D4. ALL THREE LIST NUMBERS (05J38-10, 05J38-30, AND 05J38-50) WERE INVESTIGATED AS THE ACTUAL PRODUCT USED WAS UNKNOWN. CUSTOMER DATA REVIEW THE FDA COMMUNICATION MEMO REGARDING THE CASE OPENED IN MEDWATCH WAS REVIEWED. IN THE MEMO IT IS UNCLEAR WHICH DEVICE THE COMPLAINT IS SUSPECTING (AS IT STATES BRAND NAME AS "NIPT", WHICH MOLECULAR DIAGNOSTICS DOES NOT HAVE IN ITS CATALOG) AND ONLY DESCRIBES THE MANUFACTURER OF A TRISOMY 21 TEST. THE INVESTIGATION ENCOMPASSES THE SUPPOSED US DISTRIBUTED KITS WITH THE INTENT OF TRISOMY 21 DETECTION. SUPPORTING INFORMATION REVIEW: A QUALITY DATA REVIEW WAS PERFORMED FOR PACKAGE INSERT PART# 30-608368/R6: ANEUVYSION MULTICOLOR DNA PROBE KIT PACKAGE INSERT CONTAINED IN ALL THREE KITS (LIST# 05J38-010, LIST# 05J38-030 AND LIST# 05J38-050). AS THE INFORMATION REPORTED HAD NO SPECIFICS (REGARDING ASSAY USE AND RESULTS REPORTED) THE INTENDED USE STATEMENT AND SUMMARY AND EXPLANATION SUMMARY WERE REVIEWED TO DETERMINE IF LABELING IS SUFFICIENT TO SUPPORT USE WHEN REPORTING. PACKAGE INSERT PART# 30-608368/R6: ANEUVYSION MULTICOLOR DNA PROBE KIT PACKAGE INSERT: INTENDED USE, (PAGE 1) THE ANEUVYSION (VYSIS CEP 18, X, Y-ALPHA SATELLITE, LSI 13 AND 21) MULTICOLOR PROBE PANEL IS INTENDED TO USE CEP 18/X/Y PROBE TO DETECT ALPHA SATELLITE SEQUENCES IN THE CENTROMERE REGIONS OF CHROMOSOMES 18, X, AND Y, AND LSI 13/21 PROBE TO DETECT THE 13Q14 REGION AND THE 21Q22.13 TO 21Q22.2 REGION. THE ANEUVYSION KIT IS INDICATED FOR IDENTIFYING AND ENUMERATING CHROMOSOMES 13, 18, 21, X, AND Y VIA FISH IN METAPHASE CELLS AND INTERPHASE NUCLEI OBTAINED FROM AMNIOTIC FLUID IN SUBJECTS WITH PRESUMED HIGH RISK PREGNANCIES. IT IS NOT INTENDED TO BE USED AS A STAND ALONE ASSAY FOR MAKING CLINICAL DECISIONS. FISH RESULTS ARE INTENDED TO BE USED AS AN AID IN THE DIAGNOSIS OF NUMERICAL ABNORMALITIES OF CHROMOSOMES 13, 18, 21, X AND/OR Y IN CONJUNCTION WITH OTHER INFORMATION CURRENTLY USED IN PRENATAL DIAGNOSIS, CONSISTENT WITH PROFESSIONAL STANDARDS OF PRACTICE. THIS DEVICE IS INTENDED FOR USE ONLY WITH AMNIOCYTE CELLS; IT IS NOT INTENDED FOR AND HAS NOT BEEN VALIDATED FOR USE WITH OTHER TEST MATRICES. THIS FISH ASSAY WILL NOT DETECT THE PRESENCE OF STRUCTURAL CHROMOSOME ABNORMALITIES THAT CAN ALSO RESULT IN BIRTH DEFECTS. THIS FISH ASSAY WILL BE PERFORMED IN CYTOGENETICS LABORATORIES. SUMMARY AND EXPLANATION, (PAGE 1) WOMEN AT INCREASED RISK OF CARRYING CHROMOSOMALLY ABNORMAL FETUSES ARE ROUTINELY OFFERED AMNIOCENTESIS WITH CYTOGENETIC ANALYSIS OF FETAL CELLS. INDICATIONS FOR PRENATAL DIAGNOSIS INCLUDE ADVANCED MATERNAL AGE, INCREASED RISK FOR FETAL TRISOMY IDENTIFIED BY MATERNAL SERUM SCREENING, FAMILY HISTORY, MATERNAL ANXIETY, AND ABNORMAL ULTRASOUND RESULTS. CURRENTLY, FETAL CHROMOSOME ABNORMALITIES ARE DIAGNOSED BY STANDARD CHROMOSOME ANALYSIS (EG, KARYOTYPE), A METHOD THAT DETECTS CHROMOSOME 13, 18, 21, X, AND Y ANEUPLOIDIES WITH ACCURACY AND IS ALSO CAPABLE OF DETECTING VISIBLE STRUCTURAL ABNORMALITIES. THE FISH TECHNIQUE USING CHROMOSOME-SPECIFIC DNA PROBES MAY BE USED TO ASSESS THE NUMERICAL AUTOSOMAL ABERRATIONS IN INTERPHASE CELLS IN DIRECT OR CULTURED PREPARATIONS OF AMNIOTIC FLUID SAMPLES. BECAUSE SAMPLE PROCESSING FOR FISH INTERPHASE ANALYSIS DOES NOT REQUIRE ISOLATION AND PURIFICATION OF DNA AND/OR RADIOACTIVELY LABELED DNA PROBES, FISH RESULTS ARE TYPICALLY OBTAINED PRIOR TO RECEIVING RESULTS FROM STANDARD CHROMOSOME ANALYSIS. FISH RESULTS CAN BE REPORTED IMMEDIATELY, HOWEVER, CLINICAL DECISION-MAKING ACTION BASED ON FISH RESULTS SHOULD BE CAREFULLY CONSIDERED ALONG WITH OTHER MEDICAL EVIDENCE CURRENTLY USED IN MAKING PRENATAL DIAGNOSES. THE LABELING IS SUFFICIENT TO DIRECT A CLINICIAN/PHYSICIAN THAT THE TEST(S) ARE NOT INTENDED TO BE A STAND ALONE ASSAYS FOR MAKING CLINICAL DECISIONS AND SHOULD BE USED AS AN AID IN CONJUNCTION WITH OTHER INFORMATION BEING USED FOR PRENATAL DIAGNOSIS, CONSISTENT WITH PROFESSIONAL STANDARDS. IT GOES ON TO SUPPORT IN SUMMARY AND EXPLANATION THAT CLINICAL DECISION MAKING SHOULD BE MADE WITH OTHER MEDICAL EVIDENCE. QUALITY DATA REVIEW CAPA / NON-CONFORMANCE REVIEW: A CAPA REVIEW WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT. ALL KEYWORDS IN REFERENCE TO THE DOCUMENTED ISSUE HAVE BEEN ACCOUNTED FOR IN THE SEARCH CRITERIA. THE SEARCH WAS PART-SPECIFIC FOR THE FOLLOWING LIST NUMBERS: 05J38-010, 05J38-030 AND 05J38-050 AND KEYWORDS THAT ARE RELATED TO THE DOCUMENTED ISSUE, (PRODUCT NOT MEETING SPECIFICATIONS OR PRODUCING DISCREPANT RESULTS) WERE ALSO INCLUDED IN THE SEARCH. THESE KEYWORDS INCLUDE, "INACCURATE", "DISCREPANT", "POSITIVE", "NEGATIVE" OR "RESULTS MANAGEMENT". THE CAPTURED TIME INTERVAL WAS ONE YEAR, INITIATED AFTER 03/01/2021 (1 YEAR PRIOR TO EVENT DATE). ANY RESULTING CAPA WAS THEN REVIEWED TO DETERMINE RELEVANCE TO THIS INVESTIGATION. NO CAPA WAS IDENTIFIED. COMPLAINT HISTORY REVIEW A REVIEW WAS PERFORMED IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED WHICH REPORTED AN INACCURATE RESULT FOR A DNA PROBE KIT THAT DETECTS PRENATAL ABNORMALITIES, THEREFORE THE FOLLOWING LIST#: 05J38-010, 05J38-030 AND 05J38-050 WERE SEARCHED. THE SEARCH INCLUDED KEYWORDS TO NARROW DOWN THE SEARCH TO THE DOCUMENTED ISSUE (PRODUCT NOT MEETING SPECIFICATIONS OR PRODUCING DISCREPANT RESULTS OR INACCURATE RESULTS). THESE KEYWORDS INCLUDE, "INACCURATE", "DISCREPANT", "POSITIVE", "NEGATIVE" OR "RESULTS MANAGEMENT". EACH COMPLAINT TICKET IDENTIFIED WAS REVIEWED FOR RELEVANCE TO THE CURRENT INVESTIGATION. NO RELATED COMPLAINTS WERE IDENTIFIED. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR THE FOLLOWING KITS WAS NOT IDENTIFIED: 1. ANEUVYSION MULTICOLOR DNA PROBE KIT, 10 ASSAY-IVD: PART# 33-161075 (LIST # 05J38-010). 2. ANEUVYSION MULTICOLOR DNA PROBE KIT, 30 ASSAY-IVD: PART# 32-161075 (LIST # 05J38-030). 3. ANEUVYSION MULTICOLOR DNA PROBE KIT, 50 ASSAY-IVD: PART# 35-161075 (LIST # 05J38-050).

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE FDA FORWARDED MEDWATCH FORM MW5109350 TO ABBOTT MOLECULAR. A PATIENT FILED A REPORT WITH THE FDA ON (B)(6) 2022, FOR AN OTHER SERIOUS OR IMPORTANT MEDICAL EVENT THAT OCCURRED ON (B)(6) 2022. THE DESCRIPTION OF THE EVENT STATES: I HAD A POSITIVE SCREEN ON MY NIPT (NONINVASIVE PRENATAL TESTING) FOR TRISOMY 21. CHOSE TO DO INVASIVE TESTING, WHICH PROVED TO BE INACCURATE. IT IS UNKNOWN WHAT SAMPLE TYPE WAS USED, HOW THE PROTOCOL WAS CARRIED OUT, HOW THE RESULT WAS REPORTED, AND WHEN AMNIOCENTESIS WAS ORDERED. THE IMPACT ON PATIENT MANAGEMENT IS NOT KNOWN. THE AGENCY DID NOT PROVIDE THE NAME OF THE TESTING FACILITY WHERE THE TEST WAS CARRIED OUT. THE SPECIFIC PRODUCT NAME USED IN THE TEST WAS NOT PROVIDED EITHER. HOWEVER, THE FORM LISTS THE BRAND NAME AS NIPT AND THE MANUFACTURER AS ABBOTT MOLECULAR. THE ANEUVYSION MULTICOLOR DNA PROBE KIT IS NOT A NIPT OR NIPS (NONINVASIVE PRENATAL SCREENING). NONINVASIVE PRENATAL TESTING (NIPT), SOMETIMES CALLED NONINVASIVE PRENATAL SCREENING (NIPS), IS A METHOD OF DETERMINING THE RISK THAT THE FETUS WILL BE BORN WITH CERTAIN GENETIC ABNORMALITIES. THIS TESTING ANALYZES SMALL FRAGMENTS OF DNA THAT ARE CIRCULATING IN A PREGNANT WOMAN'S BLOOD. THIS TICKET WAS ENTERED UNDER ANEUVYSION MULTICOLOR DNA PROBE KIT (10 ASSAY TEST) (LIST 05J38-10). ANEUVYSION MULTICOLOR DNA PROBE KIT COULD BE UTILIZED FOR TRISOMY 21 TESTING. THIS PRODUCT WAS CHOSEN AS IT IS THE ONLY IVD (IN VITRO DIAGNOSTIC DEVICE) MANUFACTURED BY ABBOTT MOLECULAR INTENDED TO BE USED AS AN AID IN THE DIAGNOSIS OF NUMERICAL ABNORMALITIES OF CHROMOSOMES 13, 18, 21, X AND/OR Y VIA FISH IN METAPHASE CELLS AND INTERPHASE NUCLEI OBTAINED FROM AMNIOTIC FLUID IN SUBJECTS WITH PRESUMED HIGH RISK PREGNANCIES. IT IS NOT INTENDED TO BE USED AS A STAND ALONE ASSAY FOR MAKING CLINICAL DECISIONS. TRISOMY 21 TESTING UTILIZING THE ANEUVYSION MULTICOLOR DNA PROBE KIT WOULD REQUIRE AMNIOTIC FLUID, AS PER THE PACKAGE INSERT ((B)(4)). THE PATIENT REPORTED THAT THEY RECEIVED A FALSE POSITIVE RESULT ON A NIPT FOR TRISOMY 21. NONINVASIVE PRENATAL SCREENING (NIPS) TESTS ANALYZE SMALL FRAGMENTS OF FETAL DNA, CALLED CELL-FREE DNA, THAT ARE CIRCULATING IN A PREGNANT PERSON'S BLOOD WITH THE GOAL OF DETERMINING THE RISK THAT THE FETUS HAS CERTAIN GENETIC ABNORMALITIES. WHEN USED APPROPRIATELY, THESE TESTS OFFER A NON-INVASIVE APPROACH FOR PRENATAL SCREENING AND MAY PROVIDE USEFUL INFORMATION TO ASSESS THE RISK THAT A FETUS HAS (OR DOES NOT HAVE) A GENETIC ABNORMALITY. THE NIPS TESTS CURRENTLY BEING OFFERED ARE MARKETED AS LABORATORY DEVELOPED TESTS (LDTS). THE ANEUVYSION MULTICOLOR DNA PROBE KIT IS NOT A NIPT OR NIPS TEST. IT IS THE ONLY IVD (IN VITRO DIAGNOSTIC DEVICE) MANUFACTURED BY ABBOTT MOLECULAR INTENDED TO BE USED AS AN AID IN THE DIAGNOSIS OF NUMERICAL ABNORMALITIES OF CHROMOSOMES 13, 18, 21, X AND/OR Y VIA FISH IN METAPHASE CELLS AND INTERPHASE NUCLEI OBTAINED FROM AMNIOTIC FLUID IN SUBJECTS WITH PRESUMED HIGH RISK PREGNANCIES. IT IS NOT INTENDED TO BE USED AS A STAND ALONE ASSAY FOR MAKING CLINICAL DECISIONS. PER THE LABELING, THE ANEUVYSION MULTICOLOR DNA PROBE KIT IS INTENDED FOR USE ONLY WITH AMNIOCYTE CELLS; IT IS NOT INTENDED FOR AND HAS NOT BEEN VALIDATED FOR USE WITH OTHER TEST MATRICES. THE ANEUVYSION MULTICOLOR DNA PROBE KIT WAS CHOSEN TO PERFORM THE MOST CONSERVATIVE EVALUATION. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT. AN IMPACT TO PATIENT MANAGEMENT, NAMELY AN UNSPECIFIED INVASIVE TESTING WAS PERFORMED BECAUSE OF A FALSE POSITIVE TEST RESULT USING THE ANEUVYSION MULTICOLOR DNA PROBE KIT. BASED ON THE AVAILABLE INFORMATION, THE PATIENT HAD RECEIVED NIPS (NON-INVASIVE PRENATAL SCREENING) USING THE ANEUVYSION MULTICOLOR DNA PROBE KIT. HOWEVER, THE INTENDED USE FOR THE ANEUVYSION (VYSIS CEP 18, X, Y-ALPHA SATELLITE, LSI 13 AND 21) MULTICOLOR PROBE PANEL STATES THAT IT IS INDICATED FOR IDENTIFYING AND ENUMERATING CHROMOSOMES 13, 18, 21, X, AND Y VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN METAPHASE CELLS AND INTERPHASE NUCLEI OBTAINED FROM AMNIOTIC FLUID IN SUBJECTS WITH PRESUMED HIGH RISK PREGNANCIES. THIS CONTRADICTS WITH THE STATEMENT THAT IT WAS USED FOR NONINVASIVE TESTING. AN UNNECESSARY AMNIOCENTESIS ITSELF WITHOUT ANY ADVERSE OUTCOMES IS REGARDED AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846343 ANEUVYSION MULTICOLOR DNA PROBE KIT MULTIPLE CONGENITAL ANEUPLOIDY SCREENING IVD, PROBE OYU ABBOTT MOLECULAR, INC. 05J38-010 UNKNOWN 00884999011694

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other