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

Catalog Number 02J27-011

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2015

Event Type  malfunction  

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).A customer reported that one slide in a probechek urovysion bladder kit control slides package was broken.The slides were unpacked in a different location therefore it is unknown if the slides arrived broken or if there was physical damage to the shipping box.There was no report of injury.The probechek urovysion bladder kit control slides package insert indicates that these slides contain human sourced and/or potentially infectious components.Recurrence of this event could potentially contribute to injury from the sharp slide and exposure to infectious material.

Manufacturer Narrative

(b)(4).An mdr follow-up report will be submitted after the ecinv is finalized.

Manufacturer Narrative

Summary of elevated complaint investigation (ecinv) (b)(4) for mdr 3005248192-2015-00013 follow-up report 1: the investigation included review of customer-supplied images, inspection of abbott molecular (am) retention samples from the lots in question, review of device history records, 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 manufacturing stage for specific issues including damage.Once placed into kits, the kits are sampled and inspected by quality control (qc).No issues were noted.In addition, a process is in place to minimize damage during shipment of slides from am.Review of the customer-supplied images did show damaged slides.Visual inspection of the qc retention samples from each lot in question (quantity: 3 slides per lot) showed no signs of damage.Other than the two complaints being addressed by this investigation (each complaint logged against a different lot of slides), there have been no other reports of broken slides in the past 12 months.One capa related to broken slides was identified.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 0.2% (there were 2 complaints for broken slides for 10,197 units sold), which indicates that the issue may be seen with a frequency of "occasional." no systemic product deficiency has been identified.(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 331
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 east touhy avenue; des plaines IL 60018 331
• Manufacturer Contact: jean leete ; 1300 east touhy avenue; des plaines, IL 60018-3315 ; 2243617274
• MDR Report Key: 4792395
• MDR Text Key: 5816847
• Report Number: 3005248192-2015-00013
• Device Sequence Number: 1
• Product Code: NSD
• 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: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 02J27-011
• Device Lot Number: 458159
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1