MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE PSA REAGENT KIT; TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER

Catalog Number 07K71-74

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

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 7k71 that has a similar product distributed in the us, list number 6c07.

Event Description

A literature article by gangfeng li, hongkun xu, lihong zhang, ¿a case of pseudoelevation of prostate specific antigen level¿, clinical laboratory 69.7 (jul 1, 2023), documented falsely elevated architect free psa results in a 67 year old male patient.The study noted the case of a 67 year old male patient with elevated total psa (tpsa) (1.120 ng/ml) and free psa (fpsa) (3.470 ng/ml) results tested at another hospital (shaoxing central hospital).The patient was then admitted to the urological department of shaoxing people¿s hospital on october 5, 2022 due to fpsa elevation.After admission, the patient had a prostate biopsy on october 6, and the result showed negative.At the same time, tumor markers were also tested at shaoxing people¿s hospital by an architect i2000sr immune analyzer, and the results were as follows: tpsa was 1.168 ng/ml and fpsa was 3.645 ng/ml.The results were similar to those of shaoxing central hospital.The samples were sent to two other hospitals and generated fpsa results within normal range with the beckman dxl800 analyzer and the siemens 2000xpi analyzer.The laboratory staff performed a troubleshooting study on the sample: serial dilutions: non-linear and stabilized around 8.3 ng/ml, heterophilic antibody blocking tube (hbt): did not show a significant decrease, pretreatment with peg: tpsa = 1.22 ng/ml, fpsa = 0.42 ng/ml, based on the troubleshooting study, the laboratory determined that the fpsa level of the patient should be normal and the abnormally elevated result of the abbott i2000sr immune analyzer was considered to be a pseudoelevation caused by unknown interferences.No additional impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated architect free psa results included a review of data and information within the literature article, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with list number 07k71 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.This event was caused by user error.Per product labeling intended use section: the architect free psa assay is intended to be used in conjunction with the architect total psa assay in men aged 50 years or older with total psa values between 4 and 10 ng/ml and dre non-suspicious for cancer to determine the % free psa value.The architect % free psa value can be used as an aid in discriminating between prostate cancer and benign disease.Per the limitations of the procedure section, the concentration of psa in a given specimen, determined with assays from different manufacturers, can vary due to differences in assay methods, calibration, and reagent specificity.Values obtained with different assay methods cannot be used interchangeably.The measurement of free psa or the free/total psa ratio is not an absolute test for malignancy.The psa values should be used in conjunction with information available from the clinical evaluation and other diagnostic procedures: e.G.Symptoms, clinical impressions, digital rectal examination, transrectal ultrasound, etc.In addition, per the summary and explanation of the test section of the package insert the proportion of free psa in the serum was found to be significantly higher in patients with benign prostatic hyperplasia (bph) than in patients with prostate cancer.In this case the study noted the case of a 67 year old male patient where the free psa results were greater than total psa results but total psa was <4 ng/ml.The reason the customer observed this issue could potentially be related to human anti-mouse antibodies (hama) interference which may not have been detected using the hbt blocking reagents used.A scientific article by sangtae park, frank h wians j and jeffrey a cadeddu, ¿spurious prostate-specific antigen (psa) recurrence after radical prostatectomy: interference by human antimouse heterophile antibodies¿, international journal of virology (2006) 14, 251-253, was identified that shows that hama is a potential interferent which can lead to falsely elevated free psa results.Occasionally we will see results where the fpsa result is higher than tpsa.Here are some potential explanations: ¿ the patient has an enlarged prostate and most of the psa is fpsa.¿ this sample could have autoantibodies and depending on which epitope(s) they bind, the autoantibodies could block the free or total assay more.¿ the other possibility is that in some patients there are alternate psa splice variants being made that might a) react in one of the assays and not the other or b) might compete with real psa and decrease the value, reference paper by jansen et.Al., ¿screening for prostate cancer in 2008 ii: the importance of molecular sub-forms of prostate-specific antigen and tissue kallikreins¿, european urology 55 (2009);563-574.Based on the investigation architect free psa performed as intended, no systemic issue or deficiency of the architect free psa assay was identified.

Event Description

A literature article by gangfeng li, hongkun xu, lihong zhang, ¿a case of pseudoelevation of prostate specific antigen level¿, clinical laboratory 69.7 (jul 1, 2023), documented falsely elevated architect free psa results in a 67 year old male patient.The study noted the case of a 67 year old male patient with elevated total psa (tpsa) (1.120 ng/ml) and free psa (fpsa) (3.470 ng/ml) results tested at another hospital (shaoxing central hospital).The patient was then admitted to the urological department of shaoxing people¿s hospital on october 5, 2022 due to fpsa elevation.After admission, the patient had a prostate biopsy on october 6, and the result showed negative.At the same time, tumor markers were also tested at shaoxing people¿s hospital by an architect i2000sr immune analyzer, and the results were as follows: tpsa was 1.168 ng/ml and fpsa was 3.645 ng/ml.The results were similar to those of shaoxing central hospital.The samples were sent to two other hospitals and generated fpsa results within normal range with the beckman dxl800 analyzer and the siemens 2000xpi analyzer.The laboratory staff performed a troubleshooting study on the sample: serial dilutions: non-linear and stabilized around 8.3 ng/ml heterophilic antibody blocking tube (hbt): did not show a significant decrease pretreatment with peg: tpsa = 1.22 ng/ml, fpsa = 0.42 ng/ml based on the troubleshooting study, the laboratory determined that the fpsa level of the patient should be normal and the abnormally elevated result of the abbott i2000sr immune analyzer was considered to be a pseudoelevation caused by unknown interferences.No additional impact to patient management was reported.

• Brand Name: ARCHITECT FREE PSA REAGENT KIT
• Type of Device: TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17539561
• MDR Text Key: 321065412
• Report Number: 3008344661-2023-00153
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07K71-74
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, 116UNKNOWND14; ARC I2000SR INST, 03M74-02, 116UNKNOWND14
• Patient Outcome(s): Disability
• Patient Age: 67 YR
• Patient Sex: Male