MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-27

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list (b)(4) that has a similar product distributed in the us, list number (b)(4).An evaluation is in process.(b)(4).

Event Description

The customer observed a falsely decreased architect total psa result.The customer provided the following results (ng/ml): (b)(6) 2015: initial 3.29 (b)(6) 2015: new draw: 5.35, retest 5.47 no impact to patient management was reported.

Manufacturer Narrative

On 01/07/2016 it was identified that the event description was incorrect.The corrected wording to document a falsely elevated result rather than a falsely decreased result being generated.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.Return material was not available.An accuracy testing protocol was executed using lot 54701lf00.The protocol met acceptance criteria which determined the reagent is performing acceptably.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 54701lf00, were identified.

Event Description

Correction to previously reported event description.The customer observed a falsely elevated architect total psa result as opposed to a falsely decreased architect total psa result as previously documented.

• 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 Key: 5338662
• MDR Text Key: 35255470
• Report Number: 3008344661-2015-00035
• Device Sequence Number: 1
• Product Code: MTF
• 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: 01/25/2016

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 Expiration Date: 06/03/2016
• Device Catalogue Number: 07K70-27
• Device Lot Number: 54701LF00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 12/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1