MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT; MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING

Catalog Number 02J27-11

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Summary of elevated complaint investigation (ecinv) (b)(4): this is a summary of the investigation into the complaint registered for observing damaged slides upon receipt of probechek urovysion bladder cancer control slides kit, 3 slides-ivd, part# 30-805070 (list# 02j27-011) lot# 467381.Kit lot 467381 contains probechek urovysion control slides, part# 30-505070 lot# 466535.The investigation included review of device history records, inspection of abbott molecular (am) retention samples from the lots in question, and review of capa and complaint report records.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 for specific issues including damage.Once placed into kits, the kits are sampled and inspected by quality control (qc).During inspection, one minor physical defect (label defect) was identified, and that material was removed from inventory.No other issues were noted.In addition, a process is in place to minimize damage during shipment of slides from am.Aside from the complaint currently being addressed by this investigation, one additional complaint reporting broken/damaged slides was reported in the last 12 months.One capa related to broken slides was identified ((b)(4)).This capa was opened proactively as a result of management review to make improvements in three areas to minimize the potential for broken slides.The capa was resolved in january 2014.The current complaint rate for broken slides is (b)(4) (there were (b)(4) complaints for broken slides for (b)(4) units sold), which indicates that the issue may be seen with a frequency of "occasional." no systemic product deficiency has been identified.

Event Description

The probechek urovysion control slides are non-hybridized slides prepared with cultured normal male lymphoblast cells and cultured bladder cancer cell lines.Each control slide consists of two separate target areas in which each of the different cell types have been applied.The cell lines are harvested, fixed in suspension medium and applied to the glass microscope slides in a method optimal for fish (fluorescence in situ hybridization).Customer reported that the technician opened a box of urovysion control slides and discovered broken slides.The customer reported that personal protective equipment was utilized and there were no injuries.The probechek urovysion bladder kit control slides package insert indicates that these slides contain human sourced and/or potentially infectious components.If the issue of customers receiving broken probechek slides were to recur, it is possible that customers could cut themselves with a potentially infectious slide.Therefore, recurrence of this issue could potentially cause or contribute to serious injury or death.

Manufacturer Narrative

It was identified on april 20, 2017, that upon submission of the initial report, mfr contact office - name/address/phone number had been left blank.This follow up is being submitted to provide the following information.(b)(4).

• Brand Name: PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT
• Type of Device: MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 east touhy avenue; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 east touhy avenue; des plaines IL 60018 3315
• Manufacturer Contact: kathleen zeng ; 1300 east touhy avenue.; des plaines, IL 60018-3315 ; 2243617212
• MDR Report Key: 5760643
• MDR Text Key: 48511746
• Report Number: 3005248192-2016-00004
• Device Sequence Number: 1
• Product Code: NSD
• UDI-Device Identifier: 00884999002128
• UDI-Public: (01)00884999002128(17)170208(10)467381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 02J27-11
• Device Lot Number: 467381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1