PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT 02J27-011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-05-22 for PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT 02J27-011 manufactured by Abbott Molecular, Inc..

Event Text Entries

[5816847] 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.
Patient Sequence No: 1, Text Type: D, B5


[13403171] (b)(4). An mdr follow-up report will be submitted after the ecinv is finalized.
Patient Sequence No: 1, Text Type: N, H10


[32617303] 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).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005248192-2015-00013
MDR Report Key4792395
Report Source07
Date Received2015-05-22
Date of Report2015-05-05
Date of Event2015-05-05
Date Mfgr Received2015-06-03
Date Added to Maude2015-06-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJEAN LEETE
Manufacturer Street1300 EAST TOUHY AVENUE
Manufacturer CityDES PLAINES IL 600183315
Manufacturer CountryUS
Manufacturer Postal600183315
Manufacturer Phone2243617274
Manufacturer G1ABBOTT MOLECULAR, INC.
Manufacturer Street1300 EAST TOUHY AVENUE
Manufacturer CityDES PLAINES IL 60018331
Manufacturer CountryUS
Manufacturer Postal Code60018 3315
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT
Generic NameMICROSCOPIC CONTROL SLIDES USED IN FISH TESTING
Product CodeNSD
Date Received2015-05-22
Catalog Number02J27-011
Lot Number458159
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MOLECULAR, INC.
Manufacturer Address1300 EAST TOUHY AVENUE DES PLAINES IL 60018331 US 60018 3315


Patients

Patient NumberTreatmentOutcomeDate
10 2015-05-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.