MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-25

Device Problem High Test Results (2457)

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

Event Type  malfunction  

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.Note: this report is being filed on an international product, architect total psa ln 7k70 that has a similar product distributed in the us, list number 6c06.

Event Description

The customer observed falsely elevated total psa results for one patient on the architect i2000sr analyzer.The following data was provided for a post-op patient being monitored for prostate cancer: initial 0.47 ng/ml, repeat 0.Confirmed as 0.003 ng/ml on another method.There was no impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.A review of customer field data was performed which shows no atypical performance with reagent lot 03081fn00.A review using search of the corrective and preventive actions system and manufacturing documentation did not identify issues associated with the customer's observation.Return not available.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL PSA
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8744191
• MDR Text Key: 149992637
• Report Number: 3008344661-2019-00079
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• PMA/PMN Number: P910007
• 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: 09/09/2019

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: 03/26/2020
• Device Catalogue Number: 07K70-25
• Device Lot Number: 03081FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01 SN (B)(4) ; LN 03M74-01 SN (B)(4)