MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ANEUVYSION MULTICOLOR DNA PROBE KIT; DNA-PROBE KIT, HUMAN CHROMOSOME

Catalog Number	05J38-050
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Elevated complaint investigation will be initiated.This incident is being reported to fda because the incident occurred in china using the aneuvysion multicolor dna probe kit, list number 05j38-050, which is the same/similar to the aneuvysion multicolor dna probe kit, list number 05j38-010, which received fda approval.
Event or Problem Description
The customer reported a sample with an abnormal signal when using aneuvysion dna probe kit.The customer reported on (b)(6) 2023 that the cep-y signal is small and has regular dots.On (b)(6) 2023, the customer performed karyotype analysis and a dna microarray which gave a result of y-chromosome normal.The abnormal y chromosome result was communicated to the patient.There has been no report of impact to patient management.
Additional Manufacturer Narrative
Investigation into this complaint included a retain sample evaluation, quality data review and a complaint history review.Investigation is summarized as follows: retain sample evaluation.The file sample testing for aneuvysion multicolor dna probe kit (list 05j38-050) lot 381911 met all quality specifications.File sample evaluation testing did not identify a product deficiency and was unable to reproduce the customer's weak signal intensity and non-specific signals issue.Quality data review device history record / batch record review: the device history records (dhr) review for aneuvysion multicolor dna probe kit (list 05j38-050) lot 381911 was performed.The manufacturing packets were reviewed to identify any issues related to the reported complaint during production of the lot components.No issues were identified.The products passed quality specifications at the time of release.Capa / non-conformance review: the capa review for aneuvysion multicolor dna probe kit (list 05j38-050) lot 381911 was performed to identify any records that were potentially related to the reported complaint.The search did not identify any records related to the reported issue for this lot number.Complaint history review a lot specific complaint history review was performed to identify any similar complaints to the ticket being investigated, which reported weak signal intensity and non-specific cep y so signal while using aneuvysion multicolor dna probe kit (list 05j38-050) lot 381911.A product deficiency was not identified by this evaluation.Based on the results of the investigation elements, a product deficiency for aneuvysion multicolor dna probe kit (list 05j38-050) lot 381911 was not identified.

• Brand Name: ANEUVYSION MULTICOLOR DNA PROBE KIT
• Common Device Name: DNA-PROBE KIT, HUMAN CHROMOSOME
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 east touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 east touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 east touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 18383280
• Report Number: 3005248192-2023-00327
• Device Sequence Number: 7712931
• Product Code: OYU
• UDI-Device Identifier: 00884999011717
• UDI-Public: (01)00884999011717(10)381911(11)230115(17)231226(240)05J38-050
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/26/2023
• Device Catalogue Number: 05J38-050
• Device Lot Number: 381911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown