MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE PSA; PROSTATIC SPECIFIC ANTIGEN (PSA), FREE

Catalog Number 07K71-25

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely depressed architect free psa for three patients.The following data was provided: (unit of measure = ng/ml) sample (b)(6) initial= 0, and repeat 0.681.Sample (b)(6) initial= 0, and repeat 0.349.Sample (b)(6) initial= 0, and repeat 0.080.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely depressed free psa results included a search for similar complaints, and review of result logs, trending data, labeling, and device history records, and in-house testing.Return testing was not completed as returns were not available.Trending review did not identify any trends for the complaint issue.Device history record review on lot 07193fn00 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Accuracy testing was performed using in-house retained kit of lot 07193fn00.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect free psa assay, lot number 07193fn00 was identified.

• Brand Name: ARCHITECT FREE PSA
• Type of Device: PROSTATIC SPECIFIC ANTIGEN (PSA), FREE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10178694
• MDR Text Key: 221584252
• Report Number: 3008344661-2020-00050
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2020
• Device Catalogue Number: 07K71-25
• Device Lot Number: 07193FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 08/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR PROCESSING MODULE; ARCHITECT I2000SR PROCESSING MODULE; LIST 03M74-02, SERIAL (B)(6); LIST 03M74-02, SERIAL (B)(6)