MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-30

Device Problem Low Test Results (2458)

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

Event Date 07/01/2019

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.This report is being filed on an international product, list number 07k70 that has a similar product distributed in the us, list number 6c06.

Event Description

The customer observed falsely depressed architect total psa (prostate specific antigen) results for 1 sample.The following data was provided (units of measure = ng/ml): total psa results = 0.492, 0.521, 0.518, repeated at another laboratory = 1.51, repeat on alinity = 2.54.No impact to patient management was reported.

Manufacturer Narrative

Correction: new data received on 02oct2019, repeat on alinity = 2.54 was corrected to repeat on alinity = 0.49.A review of tickets was performed for reagent lot number 94020fn00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Validated instrument data analytics (ida) reports were used to evaluate the performance of the architect total psa assay.Reagent lot 94020fn00 is comparable with other lots in the field and within established baselines, confirming no systemic issue for the lot.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect total psa assay for lot 94020fn00 was identified.

Event Description

The customer observed falsely depressed architect total psa (prostate specific antigen) results for 1 sample.The following data was provided (units of measure = ng/ml): total psa results = 0.492, 0.521, 0.518, repeated at another laboratory with siemens analyzer = 1.51, repeat on alinity = 0.49 no impact to patient management was reported.

• 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: 8803580
• MDR Text Key: 151484082
• Report Number: 3008344661-2019-00086
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Catalogue Number: 07K70-30
• Device Lot Number: 94020FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, SERIAL (B)(4); ARCHITECT I2000SR ANALYZER, SERIAL (B)(4); LIST 03M74-01; LIST 03M74-01; ARCHITECT I2000SR ANALYZER, SERIAL (B)(4); LIST 03M74-01