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 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event occurred in: (b)(6).

Event Description

The customer experienced an issue where the elecsys free psa immunoassay results were higher than the elecsys total psa immunoassay results for one patient.The customer used a cobas e 411 immunoassay analyzer with a serial number of (b)(4).The initial free psa result was 0.426 ng/ml and the initial total psa result was 0.165 ng/ml.The sample was repeated with a free psa result of 0.427 ng/ml and a total psa result of 0.151 ng/ml.An aliquot of the same sample was tested in another laboratory using the same elecsys test.The free psa result was 0.440 ng/ml and a total psa result of 0.12 ng/ml.The results were not reported outside of the laboratory.There was no allegation of an adverse event.Refer to the medwatch with (b)(6) for the free psa assay.

Manufacturer Narrative

The patient sample was submitted for investigation.The customer¿s results of free psa and total psa are reproducible and their complaint has been confirmed.The erroneous result of total psa may be caused by the presence of a rare isotype of total psa or unknown interfering component in the patient sample.Product labeling for total psa states "it is known that in rare cases psa isoforms do exist which may be measured differently by different psa tests.Findings of this kind have occasionally been reported for psa tests from various manufacturers.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." investigation was performed by adding an additional biotinylated anti-psa antibody with a different specificity.This approach gives a result for the free psa/total psa ration of <1 in the investigated patient sample.The customer was not using rack adapters.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6969209
• MDR Text Key: 90773955
• Report Number: 1823260-2017-02402
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

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 Catalogue Number: 04641655190
• Device Lot Number: 24704501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1