MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-27

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product list 7k70, that has a similar us product distributed in the us, list 6c06.An evaluation is in process.A follow up report will be submitted when the evaluation is completed.

Event Description

The account generated a false elevated architect total psa of 140.9 ng/ml on a patient that did not have a diagnosis of prostate cancer.The sample repeated 28.858 (neat) but 144.29 ng/ml (1:5 diluted).No impact to patient management was reported.Race and ethnicity of the patient is unknown.

Manufacturer Narrative

Lot updated from unknown to 95445fn00.A review of result logs for instrument serial (b)(4).Was performed and confirms the customers observation for elevated total psa results for one sample draw.A new sample draw was tested within close proximity on the same instrument using the same reagent lot and a result of 28.858 ng/ml was obtained.Controls were running as expected.It is possible that the initial elevated results were due to a specimen issue.Additionally, the reviewed results show no atypical signal profiles for the 2 samples processed.The ticket searches determined normal complaint activity for the likely cause lot.Complaint trending report review determined that there is no adverse trend for the product for the complaint issue.Instrument data analytics was reviewed which determined that the patient median result for the complaint lot is comparable with other lots in the field and confirms no systemic issue for the lot.No customer returns were available for evaluation.A review of the product quality history for the lot number using search of the corrective and preventive actions system did not identify issues associated with the customer observation.Labeling was reviewed which adequately addresses the current issue.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: 8828883
• MDR Text Key: 160373582
• Report Number: 3008344661-2019-00091
• 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: 09/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2020
• Device Catalogue Number: 07K70-27
• Device Lot Number: 95445FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR LIST 03M74-01; ARCHITECT I2000SR LIST 03M74-01; SERIAL (B)(4); SERIAL (B)(4)
• Patient Age: 63 YR