MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-25

Device Problems False Reading From Device Non-Compliance (1228); High Test Results (2457)

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

Event Date 04/05/2014

Event Type  malfunction  

Event Description

The customer observed falsely elevated architect total psa results for one patient.The customer indicated the (b)(6) male patient had been diagnosed with prostatic hyperplasia in 2003.Since that time the patient clinical results have remained around 5.0.The results generated on (b)(6) 2014 (sid (b)(6)) were elevated: initial 12.11 ng/ml, retest 12.38 ng/ml.Reproducibility testing was completed on (b)(6) 2014; generating elevated results: 13.757, 13.612 ng/ml.There was no adverse impact to patient management reported.

Manufacturer Narrative

This report is being filed on an international product, list 07k70 that has a similar product distributed in the us, list number 06c06.(b)(4).A follow-up report will be submitted when the evaluation is complete.An evaluation is in-process.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, in-house testing, a batch record review, a search for similar complaints, and a review of labeling.An accuracy testing protocol was executed using lot 33190lf00 and met acceptance criteria which determined the reagent is performing acceptably.Return material was not available.A batch record review did not identify any issues.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no malfunction and no product deficiency of the architect total psa reagent list number 07k70, lot number 33190lf00, were identified.

• 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 ; 847937-512
• MDR Report Key: 3775745
• MDR Text Key: 4430594
• Report Number: 3008344661-2014-00018
• 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,Followup
• Report Date: 04/06/2014

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: Other
• Device Expiration Date: 09/23/2014
• Device Catalogue Number: 07K70-25
• Device Lot Number: 33190LF00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2014
• Initial Date FDA Received: 04/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2013
• 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,; LN 01L86-01, SN (B)(4); ARCHITECT I1000SR ANALYZER,
• Patient Age: 66 YR