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
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Elevated complaint investigation has been initiated.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005248192-2020-00002
• Device Sequence Number: 3432155
• Product Code: NSD
• UDI-Device Identifier: 00884999002128
• UDI-Public: 00884999002128
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 05/13/2020
• Device Model Number: 02J27-011
• Device Catalogue Number: 02J27-11
• Device Lot Number: 497909
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1