MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT-IVD; FLUORESCENCE IN SITU HYBRIDIZATION, ANAPLASTIC LYMPHOMA KINASE, GENE REARRANGEME

Catalog Number	06N38-005
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being reported to fda because the incident occurred in china using the probechek alk negative control slides kit-ivd, list number 06n38-005, which received fda approval.The device listing, probechek alk negative control slides kit-ivd, list number 06n38-005 is marked as a combination product, however; due to the nature of the event being a damaged slide, no further information is required.Investigation into this complaint included inspection of retention samples, a quality data review and a complaint history review.Investigation is summarized as follows: retain sample evaluation: the file sample in question, probechek alk negative control slides kit-ivd (5 slides): list# 06n38-005/lot# 396662 (containing individual slides: probechek alk negative control slide-ivd: part #31-505030/lot# 399173) was visually inspected for damage.No physical damaged was identified as a result of the inspection.Quality data review: batch record review.Batch records were reviewed probechek alk negative control slides kit-ivd (5 slides): list# 06n38-005/lot# 396662 as well as records for the slides: probechek alk negative control slide-ivd: part #31-505030/lot# 399173.There were no issues noted in manufacturing and slides are labeled and inspected during slide kit manufacturing.No slide damage was identified during manufacture of either the slides or the slide kits.Nonconformance (nc) / corrective and preventive action (capa) search: a search of nc and capa (nc/capa) records was performed for instances related to the probechek alk negative control slides kit-ivd (5 slides): list# 06n38-005/lot# 396662 as well as records for the slides: probechek alk negative control slide-ivd: part #31-505030/lot# 399173.The capa review did not identify any existing internal issues or nonconformances related to the reported complaint.Complaint history review: complaint history review was performed for the probechek alk negative control slides kit-ivd (5 slides): list# 06n38-005/lot# 396662 and no product deficiency was identified.Based on the results of the investigation elements, a product deficiency for probechek alk negative control slide-ivd: part #31-505030/lot# 399173 (contained in kit: probechek alk negative control slides kit-ivd (5 slides): list# 06n38-005/lot# 396662) was not identified.
Event or Problem Description
The customer reported receipt of a broken slide of probechek alk negative control slides ii.There was no injury or impact as a result of the broken slide.
Additional Manufacturer Narrative
Corrections: corrected h6 health effect - impact code from 2645 to 2199.

• Brand Name: PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT-IVD
• 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 60118 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60118 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60118-3315 ; 2242064064
• MDR Report Key: 20020979
• Report Number: 3005248192-2024-00132
• Device Sequence Number: 7476299
• Product Code: OWE
• UDI-Device Identifier: 00884999025721
• UDI-Public: (01)00884999025721(10)396662(17)250214(240)06N38-005
• Combination Product (Y/N): Y
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 02/14/2025
• Device Catalogue Number: 06N38-005
• Device Lot Number: 396662
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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