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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 06C06-27
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2018
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed a falsely elevated total psa result on the architect i1000sr aanlyzer.The following data was provided: sid (b)(4) initial 32.64 ng/ml repeated 0.12, 0.14 and 0.12.There was no impact to patient management reported.
 
Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.No return patient sample was available.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation 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
MDR Report Key8188954
MDR Text Key131381426
Report Number3008344661-2018-00110
Device Sequence Number1
Product Code MTF
UDI-Device Identifier00380740008987
UDI-Public00380740008987
Combination Product (y/n)N
PMA/PMN Number
P910007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/05/2019
Device Catalogue Number06C06-27
Device Lot Number89009FN00
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I1000SR ANALYZER; ARCHITECT I1000SR ANALYZER, LN 01L86-01; LN 01L86-01 SN (B)(4); SN (B)(4)
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