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 Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of discrepant results for 1 patient sample tested for elecsys total psa immunoassay (total psa) and elecsys free psa immunoassay (free psa) on a cobas 6000 e 601 module.This medwatch will cover total psa.Refer to medwatch with patient identifier (b)(6) for information on the free psa erroneous results.The initial total psa result from the e601 module was 0.583 ng/ml.The sample was repeated on a different e601 module and the result was 0.584 ng/ml.The initial free psa result from the e601 module was 1.44 ng/ml.The sample was repeated on a different e601 module and the result was 1.46 ng/ml.The same sample was repeated by an unspecified chemiluminescence method and the total psa result was 6.71 ng/ml.No incorrect results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e601 module serial number used for the initial results was (b)(4).The serial number for the e601 module used for repeat testing was not provided.

Manufacturer Narrative

No issues were identified during a review of calibration and qc data.

Manufacturer Narrative

An assay related issue was not detected.The patient sample was submitted for investigation.The investigation was able to reproduce the customer's allegation.The low total psa results were caused by an endogenous interfering substance affecting the epitope or the paratope of the anti-psa anitbody.

• 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: 7331228
• MDR Text Key: 102336450
• Report Number: 1823260-2018-00773
• 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,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 04641655190
• Device Lot Number: 247045
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1