MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT TOTAL PSA

Catalog Number 07K70-20

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

The customer stated that the architect analyzer generated falsely elevated total psa results on one patient sample compared to a previous result.The results provided: (b)(6) 2014 = 4.4ng/ml / previous test, date unknown 2.3ng/ml (normal range <4ng/ml).There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Further evaluation of the customer issue included a review of the complaint text, a review for similar complaints, and a review of labeling.The customer reported a falsely elevated architect total psa patient result of 4.4ng/ml with an unknown lot of architect total psa 7k70-25.The previous result for the patient (unknown date) was 2.3ng/ml.The sample was also tested with an unspecified method at another laboratory and a result of greater than 4 was obtained.The customer confirms that the instrument is operating as expected.A review of complaints determined that complaint activity was normal for falsely elevated total psa results.An additional investigation could not be performed as the reagent lot number was unknown.There was no patient sample available for return.There is not enough information to reasonably suggest a malfunction.A review of labeling states that values obtained with different assay methods cannot be used interchangeably.No additional issues were identified; no further action is required at this time.

• 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: 3998318
• MDR Text Key: 4816745
• Report Number: 3008344661-2014-00030
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07K70-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER, LIST # 01L86-01,; SERIAL # (B)(4)