MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-25

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2014

Event Type  malfunction  

Event Description

The customer stated that erratic architect total psa results were generated on a prostate cancer patient.End of 2013, 4.94 ng/ml.(b)(6) 2014, 36.25 ng/ml.(b)(6) 2014, 216 ng/ml.(b)(6) 2014, 172 ng/ml.(b)(6) 2014, 283 ng/ml.The patient was started on hormone therapy.(b)(6) 2014, 369 ng/ml.(b)(6) 2014, 85 ng/ml.The clinical doctor questioned the results as the variation in the results is too large, especially for the sample from august.There was no report of impact to patient management.

Manufacturer Narrative

(b)(4).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 7k70 that has a similar product distributed in the us, list number 6c06.

Manufacturer Narrative

The customer reported a falsely depressed total psa patient result of 85 ng/ml (measured on (b)(6) 2014) using architect total psa 7k70-25 lot 38558lf00) for a (b)(6) prostate cancer patient undergoing hormone therapy.The sample from august was also tested at a reference laboratory and a similar result was obtained.Good dilution linearity was also observed.The customer confirms that the control values were as expected.Customer complaint data was reviewed and no adverse trends were identified.Testing of a serum based panel sample with a target concentration of 32.4 ng/ml, which mimics a patient sample, was performed using in-house retained kits.All acceptance specifications were met indicating that the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer observation.The architect total psa reagent package insert was reviewed and was found to adequately address the issue.Per product labeling hormonal therapy may affect psa expression; therefore, a low psa level after any treatment that includes hormonal therapy may not adequately reflect the presence of residual or recurrent disease.Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (hama).Specimens containing hama may produce anomalous values when tested with assay kits such as architect total psa that employ mouse monoclonal antibodies.Architect total psa reagents contain a component that reduces the effect of hama reactive specimens.The investigation did not identify a malfunction / deficiency.

• Brand Name: ARCHITECT TOTAL PSA
• Type of Device: TOTAL PSA
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer (Section G): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 4045171
• MDR Text Key: 4860374
• Report Number: 3008344661-2014-00033
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P910007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2015
• Device Catalogue Number: 07K70-25
• Device Lot Number: 38558LF00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER 3M74-01; ARCHITECT I2000SR ANALYZER 3M74-01; SN (B)(4); SN (B)(4)
• Patient Age: 65 YR