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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TOTAL PSA; TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER
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ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TOTAL PSA; TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER Back to Search Results
Catalog Number 07K70-27
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/22/2023
Event Type  malfunction  
Event Description
The customer observed falsely elevated architect total psa (prostate specific antigen) results for one patient.The patient was historically in the normal range.The following data was provided: the patient tested annually as part of health screening and around september the value went up by almost 20.No treatment was given based on the result and the patient was tested at a hospital and examined with normal results.No further data or exact values are available.There was no impact to patient management reported.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Manufacturer Narrative
The complaint investigation for falsely increased architect total psa lot unknown results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review on the list number did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Customer field data was used to assess the performance of the architect total psa assay using worldwide data through abbottlink.The likely cause lot is unknown in this case, however review of the within date lots show that all median values are within ±2sd of the mean indicating that the lots are comparable and performing acceptably in the field.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the architect total psa assay was identified.
 
Event Description
The customer observed falsely elevated architect total psa (prostate specific antigen) results for one patient.The patient was historically in the normal range.The following data was provided: the patient tested annually as part of health screening and around september the value went up by almost 20.No treatment was given based on the result and the patient was tested at a hospital and examined with normal results.No further data or exact values are available.There was no impact to patient management reported.
 
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Brand Name
ARCHITECT TOTAL PSA
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 Key17087386
MDR Text Key316945956
Report Number3008344661-2023-00102
Device Sequence Number1
Product Code MTF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P910007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07K70-27
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/28/2023
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 Number1
Treatment
ARC I2K PROC MOD, 03M74-01, ISR61935; ARC I2K PROC MOD, 03M74-01, ISR61935
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