MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-35

Device Problem High Test Results (2457)

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

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect total psa, list 7k70, that has a similar product distributed in the us, list 6c06.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 Description

The customer observed falsely elevated total psa results on the architect i2000sr analyzer.The following data was provided (ng/ml): sid (b)(6) initial 185.656, repeat 74.386.Sid (b)(6) initial 300.749, repeat 259.859.Sid (b)(6) initial 272.817, repeats 154.871, 67.634.There was no negative impact to patient management reported.

Manufacturer Narrative

Additional patient information was provided on aug 16, 2019.When the patient had a bone biopsy, they found that he had a bone tumor caused by the metastasis of the prostate.The patient saw another urologist, and he did not see anything unusual on the rectal examination.They again sent the sample to the reference hospital for psa, and this time it did come out high on another method.In the end, the clinician correctly operated on the patient, and he had a tumor in the prostate.The customer indicated the initial architect result was not falsely elevated, it matched the clinical indication of the patient.The customer is no longer alleging a malfunction.There was no discrepant data and no impact to patient management.Based upon this new information, this complaint is no longer a reportable event and no further follow up will be provided.

• 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: 8838431
• MDR Text Key: 160377136
• Report Number: 3008344661-2019-00094
• Device Sequence Number: 1
• Product Code: MTF
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07K70-35
• Device Lot Number: 91375FN00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/16/2019
• 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)