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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA
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ABBOTT IRELAND ARCHITECT TOTAL PSA Back to Search Results
Catalog Number 07K70-30
Device Problem False Positive Result (1227)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/10/2014
Event Type  malfunction  
Event Description
The customer stated that architect total psa results of 5.47 and 5.35 ng/ml were generated for a male patient (sample id (b)(6)) on (b)(6) 2014.The patient previously tested between 0.7 and 0.9 ng/ml at another facility.The patient was redrawn after (b)(6) 2014 at another facility and the result was 0.9 ng/ml.No adverse impact to patient management was reported.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).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
Dilution linearity could not be assessed to check for non specific reaction as the patient sample is unavailable.No clinical information is available for the patient.Historical complaint review determined that there is no unusual activity for the likely cause lot and that there is no non statistical or adverse trend for the product.As no patient sample was available for investigation, testing of a serum based panel sample with a target concentration of 3.5 ng/ml, which mimics a patient sample, was performed using inhouse retained kits stored at the recommended storage condition.All specifications were met indicating that lot 41316lf00 is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A review of labeling concluded that the issue is sufficiently addressed.Based on results of the investigation, the assay performed as intended and no product deficiency was identified.
 
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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 Key4256294
MDR Text Key18032693
Report Number3008344661-2014-00042
Device Sequence Number1
Product Code LTJ
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 10/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/26/2015
Device Catalogue Number07K70-30
Device Lot Number41316LF00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LIST 03M74-01, SERIAL (B)(4); ARCHITECT I2000SR ANALYZER
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