MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. PROBECHEK UROVYSION CONTROL SLIDE; TEST, FLUORESCENCE IN SITU HYBRIDIZATION (FISH), FOR BLADDER CANCER DETECTION

Model Number 02J27-011

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Elevated complaint investigation has been initiated.

Event Description

Customer reports receipt of broken probechek urovysion control slides.There was no patient involved as the wholesaler discovered it on (b)(6) 2020, and contacted his sales representative.There were no injuries associated with this observation.This incident is being reported to fda because the incident occurred in (b)(6) using probechek urovysion control slides, list number 02j27-11, which is also us fda approved.

Manufacturer Narrative

Investigation into this complaint included an evaluation of the quality data review (device history record (dhr) review and capa review), complaint history review, and inspection of abbott molecular (am) retains from the same lot of material in question.The results of the investigation are summarized as follows: the device history record / batch record review identified no errors or issues.The products under investigation met inspection requirements at the time of release.A process review indicated slides are inspected at regular intervals for damage in the manufacturing process and that slides are packed and shipped sufficiently to minimize damage.Capa / non-conformance review identified no related non-conformance or capa records within the last two years.Retain / file sample evaluation: a visual inspection using am retain sample from the same lot of material in question was performed to determine if products had any visually identifiable damage.No damage was identified.Complaint history review identified the complaint addressed here as the only ticket reporting broken/damaged slides in the last year.No additional complaints were identified.Based on the results of the investigation elements, a product or systemic deficiency for probechek urovysion control slides: part# 30-505070/lot# 496330 (kit: probechek urovysion bladder cancer kit control slides: part# 30-805070 (list# 02j27-011)/lot# 497909) has not been identified.

• Brand Name: PROBECHEK UROVYSION CONTROL SLIDE
• Type of Device: TEST, FLUORESCENCE IN SITU HYBRIDIZATION (FISH), FOR BLADDER CANCER DETECTION
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines, il
• MDR Report Key: 9747843
• MDR Text Key: 191918381
• Report Number: 3005248192-2020-00002
• Device Sequence Number: 1
• Product Code: NSD
• UDI-Device Identifier: 00884999002128
• UDI-Public: 00884999002128
• Combination Product (y/n): N
• PMA/PMN Number: P030052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/13/2020
• Device Model Number: 02J27-011
• Device Catalogue Number: 02J27-11
• Device Lot Number: 497909
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1