MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number	06C06-27
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported that a tech was placing the septum on the total psa conjugate bottle when his finger went through the septum causing the septum to sink into the vial and fluid to splash on his eyelid.The tech thoroughly rinsed his eye, but declined any further medical attention.The tech was wearing a lab coat and gloves, but no eye protection.There was no adverse impact to the employee reported.
Additional Manufacturer Narrative
A review of complaints found no trends for the complaint issue.Return testing was not completed as returns were not necessary.The architect total psa package insert states that this product contains human sourced and/or potentially infectious components and should be considered potentially infectious.It is recommended that these reagents and human specimens be handled in accordance with the osha standard on bloodborne pathogens.In addition, the safety data sheet (sds) for the architect total psa states that if the material comes in contact with the eye to rinse cautiously with water for several minutes.If eye irritation persists, get medical advice/attention.Wear safety glasses or other protective eyewear.If splash potential exists, wear full face shield or goggles.The sds documents that there is no irritant effect to eyes by the reagent.The event is a use error as the customer did not follow the safety instructions as outlined in the architect total psa package insert and the safety data sheet (sds).Based on our investigation no product deficiency was identified for the architect total psa reagent, list number 06c06.

• Brand Name: ARCHITECT TOTAL PSA
• Common Device Name: TOTAL PSA
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 9505678
• Report Number: 3008344661-2019-00153
• Device Sequence Number: 1853785
• Product Code: MTF
• UDI-Device Identifier: 00380740008987
• UDI-Public: 00380740008987
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P910007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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: Health Professional
• Device Catalogue Number: 06C06-27
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER, LN 03M74-02,; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4)