MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA); TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS

Catalog Number 04641655190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The customer complained of questionable elecsys free psa immunoassay (freepsa) and elecsys total psa immunoassay (tpsa) results for 1 patient tested on a cobas e 411 immunoassay analyzer.The customer tested two separate samples (sample a and sample b) from the same patient.This medwatch will cover tpsa.Please refer to the medwatch with patient identifier (b)(6) for information on the freepsa.For sample a: the initial tpsa result was 0.154 ng/ml with a repeat result of 0.163 ng/ml.The initial freepsa result was 4.91 ng/ml with a repeat result of 4.89 ng/ml.For sample b: on (b)(6) 2018 the initial tpsa result was 0.207 ng/ml.The same patient sample was tested on a cobas 8000 and a tpsa result of 0.158 ng/ml was obtained.On (b)(6) 2018 the initial freepsa result was 5.05 ng/ml.The same patient sample was tested on a cobas 8000 and a freepsa result of 4.43 ng/ml was obtained.The erroneous results were not reported outside of the laboratory.There was no allegation of an adverse event.The cobas e411 serial number was (b)(4).The investigation is currently ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8178448
• MDR Text Key: 131144264
• Report Number: 1823260-2018-04982
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• PMA/PMN Number: P990056
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04641655190
• Device Lot Number: 31571405
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1