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

Catalog Number	06N38-10
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.
Event or Problem Description
The probechek alk positive control slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the vysis alk break apart fish probe kit (list no.06n38).The probechek alk positive control slides should be assayed in conjunction with the user's specimen slides according to the package insert for the vysis alk break apart fish probe kit (list no.06n38).Customer reported that when opening alk positive control slides one slide was broken.The customer did not report any injury.Lab technician was wearing protective equipment.The outer box appeared to be slightly recessed like pressure had been put on it.The probechek alk positive control slide package insert indicates these slides contain human sourced and/or infectious components.If this event were to recur, it is possible customers could cut themselves with a potentially infectious slide.There is no patient involved as the broken slide was observed during opening of the product by a laboratory technician.
Additional Manufacturer Narrative
Summary of complaint investigation for complaint ticket (b)(4).Investigation into this complaint included an evaluation of the quality data review, complaint history review, and inspection of abbott molecular (am) retains from the same lot of material in question.Related manufacturing and test records were reviewed, and no errors were identified.The manufacturing process is a manual process.Slides are 100% inspected at the kit manufacturing stage.Once placed into kits, the kits are sampled and inspected by quality control.No issues were noted during inspection.In addition, a process is in place to minimize damage during shipment of slides from am.A visual inspection using am retain samples from the same lot of material in question was performed to determine if products had any visually identifiable damage.No damage was identified.Aside from the complaint currently being addressed by this investigation, two additional complaints reporting broken/damaged slides were reported in the last 12 months.The current complaint rate for broken slides is 0.04% (3 complaints for broken slides for 7,511 units sold), indicating that the issue may be seen with a frequency of "occasional." based on the results of investigation no systemic product deficiency has been identified.

• Brand Name: PROBECHEK ALK POSITIVE CONTROL SLIDES
• 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
• MDR Report Key: 7298180
• Report Number: 3005248192-2018-00001
• Device Sequence Number: 19141642
• Product Code: OWE
• UDI-Device Identifier: 00884999025738
• UDI-Public: 00884999025738
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P110012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: No Information
• Device Expiration Date: 08/07/2018
• Device Catalogue Number: 06N38-10
• Device Lot Number: 479393
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1