MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-25

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2014

Event Type  malfunction  

Event Description

The customer observed a falsely elevated total psa result for one (b)(6)-year old patient on the architect i1000sr analyzer.The following data was provided: initial (b)(6) 46.02 ng/ml, retested (b)(6) as 21.03 ng/ml.An mri was performed on (b)(6) and there was no signs of cancer.Free psa was tested as 3.586, 3.575, 3.581.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.(b)(4) no known impact or consequence to patient this report is being filed on an international product, architect total psa list 7k70 that has a similar product distributed in the us, list number 6c06.An evaluation is in process.

• Brand Name: ARCHITECT 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 ; 847937-512
• MDR Report Key: 3647686
• MDR Text Key: 4182184
• Report Number: 3008344661-2014-00015
• 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: Health Professional
• Type of Report: Initial
• Report Date: 02/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07K70-25
• Device Lot Number: 31322LF00
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2014
• Initial Date FDA Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LN 01L86-01 SN (B)(4); ARCHITECT I1000SR ANALYZER
• Patient Age: 80 YR
• Patient Sex: Male