MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. VYSIS ALK BREAK APART FISH PROBE KIT; FLUORESCENCE IN SITU HYBRIDIZATION, ANAPLASTIC LYMPHOMA KINASE, GENE REARRANGEME

Catalog Number	06N38-033
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 vysis alk break apart fish probe kit, list 06n38-033, which is also us fda approved.
Event or Problem Description
The customer reported a false negative result on the vysis alk break apart fish.The customer tested a sample and found that immunohistochemistry (ihc) results and pcr results were 90% positive, but the fish results were less than 5%.The vysis alk break apart fish's manufacture date was may 2023 and expiration date was april 2024.The kit was expired at the time of the reported event.The customer reported that they can see all fusion signal and did not believe the expired kit would cause different results between the ihc and pcr.There was no report of impact to patient management.The negative result was reported outside of the laboratory.
Event or Problem Description
The customer reported a false negative result on the vysis alk break apart fish.The customer tested a sample and found that immunohistochemistry (ihc) results and pcr results were 90% positive, but the fish results were less than 5%.The vysis alk break apart fish's manufacture date was may 2023 and expiration date was april 2024.The kit was expired at the time of the reported event.The customer reported that they can see all fusion signal and did not believe the expired kit would cause different results between the ihc and pcr.There was no report of impact to patient management.The negative result was reported outside of the laboratory.Additional information was provided, the customer did not know the lot number for list number 06n38-33.However, the customer provided the following: vysis lsi alk dual color break apart fish probe 200ul, ivd: part number (pn) 31-190068, lot number 518571.The customer used the probe in question after the expiration date of 5/14/2023.
Additional Manufacturer Narrative
Investigation into this complaint included a quality data review, capa/non-conformance review, and a complaint history review.Investigation is summarized as follows: quality data review device history record / batch record review: a quality data review was performed for the following complaint component, vysis lsi alk dual color break apart fish probe 200ul, ivd: part#: 31-190068/lot# 518571 and bulk formulation used to manufacture the complaint component (lsi alk dc bap ffpe fish probe bulk formulation: part# 30-190168/lot# 517425) was reviewed to identify any issues related to the reported complaint during production of the probe and its bulk component.Batch records were reviewed.No errors were identified.Verified product met specifications at time of release.Specifications include but are not limited to cytogenetic verification of probes, functional parameters (intensity, background, cross-hybridization, specificity and counterstain quality) and enumeration data.Related products in question were quality control tested and met all quality specifications.Dhr review indicates bottle and bulk probe testing meet all quality specifications with no indication of performance issues.Record review did not identify a product deficiency.Capa / non-conformance review: a capa review was performed to identify any records that were related to the reported complaint for probe in question (vysis lsi alk dc bap fish probe 200ul, ivd: part#: 31-190068/lot# 518571 and the bulk material used to manufacture the probe in question (lsi alk dc bap ffpe fish probe bulk formulation: part# 30-190168/lot# 517425).The capa review did not identify any existing internal issues or records related to/impacting the reported complaint.Complaint history review: a lot specific complaint history review was performed to identify any similar complaints to the ticket being investigated.No additional complaints were identified.Additionally, complaint trending was completed.A trend violation was not identified, and the upper control limit was not exceeded for product 06n38 (trending part number).No adverse trend was identified.Based on the results of the investigation elements, a product deficiency for vysis lsi alk dual color break apart fish probe 200ul, ivd: part#: 31-190068/lot# 518571 was not identified.

• Brand Name: VYSIS ALK BREAK APART FISH PROBE KIT
• Common Device Name: FLUORESCENCE IN SITU HYBRIDIZATION, ANAPLASTIC LYMPHOMA KINASE, GENE REARRANGEME
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 20076816
• Report Number: 3005248192-2024-00137
• Device Sequence Number: 6414549
• Product Code: OWE
• UDI-Device Identifier: 00884999042728
• UDI-Public: (01)00884999042728(240)06N38-033
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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 Catalogue Number: 06N38-033
• 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: 08/10/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown