MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FREE PSA; TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA

Catalog Number 03289788190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter received questionable elecsys free psa immunoassay results for one patient from cobas 6000 e 601 module serial number (b)(4).The initial result was >50 ng/ml.On (b)(6) 2019, the customer pre-diluted the sample 1:2 and 1:5 using a sample from a woman and the results were >50 ng/ml.The sample was tested on an abbott architect analyzer and the result was 15.85 ng/ml.This result was reported outside of the laboratory.On (b)(6) 2019, the sample was tested on another cobas e601 at a different site and the result was >50 ng/ml.A 1:20 pre-dilution was performed and the result was 260 ng/ml.There was no allegation of an adverse event.

Manufacturer Narrative

The calibration and qc data was acceptable.Therefore, a general reagent issue could be excluded.A sample from the patient was provided for investigation and both the free and total psa results were confirmed.As there was not enough sample volume left for further investigation, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: FREE PSA
• Type of Device: TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8703371
• MDR Text Key: 148172755
• Report Number: 1823260-2019-02198
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

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: 09/30/2019
• Device Catalogue Number: 03289788190
• Device Lot Number: 33081403
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 05/27/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR