MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. PROBECHEK CONTROL SLIDES FOR PATHVYSION HER-2 DNA PROBE KI; SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM

Model Number	02J04-030
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they received a broken slide contained within probechek her-2/neu control slides for fluorescence in situ hybridization (fish) using pathvysion her-2 dna probe kit.The customer confirmed no one on site was injured by the broken slides.Customer stated that they did not attempt to use the broken slide.
Additional Manufacturer Narrative
Full brand name is probechek her-2/neu control slides for fluorescence in situ hybridization (fish) using pathvysion her-2 dna probe kit.Elevated complaint investigation has been initiated.
Additional Manufacturer Narrative
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 pathvysion her-/neu cut-off control slides-ivd (5 slides): part# 30-805042 (list# 02j04-030)/lot# 381348 (containing slides: probechek pathvysion her-/neu cut-off control slides: part# 30-505042/lot# 530873) was visually inspected for damage.No physical damaged was identified as a result of inspection.Quality data review batch record review batch records were reviewed for probechek pathvysion her-/neu cut-off control slides-ivd (5 slides): part# 30-805042 (list# 02j04-030)/lot# 381348 as well as records for the slides: probechek pathvysion her-/neu cut-off control slides: part# 30-505042/lot# 530873.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 pathvysion her-/neu cut-off control slides-ivd (5 slides): part# 30-805042 (list# 02j04-030)/lot# 381348 as well as records for the slides: probechek pathvysion her-/neu cut-off control slides: part# 30-505042/lot# 530873.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 pathvysion her-/neu cut-off control slides-ivd (5 slides): part# 30-805042 (list# 02j04-030)/lot# 381348 and no product deficiency was identified.Based on the results of the investigation elements, a product deficiency for probechek pathvysion her-/neu cut-off control slides-ivd: part# 30-505042/lot# 530873 (contained in kit: probechek pathvysion her-/neu cut-off control slides-ivd (5 slides): part# 30-805042 (list# 02j04-030)/lot# 381348) was not identified.

• Brand Name: PROBECHEK CONTROL SLIDES FOR PATHVYSION HER-2 DNA PROBE KI
• Common Device Name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
• 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: 15711041
• Report Number: 3005248192-2022-00941
• Device Sequence Number: 15075480
• Product Code: MVD
• UDI-Device Identifier: 00884999001831
• UDI-Public: 00884999001831
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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
• Device Expiration Date: 06/08/2023
• Device Model Number: 02J04-030
• Device Catalogue Number: 02J04-30
• Device Lot Number: 381348
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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