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 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This 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 two patients.The customer used the cobas 8000 e 602 module serial number (b)(4).For patient 1 the free psa result was 2.19 ng/ml and the total psa result was 0.07 ng/ml.For patient 2 on (b)(6) 2017 the free psa result was 3.7ng/ml and the total psa result was 0.065 ng/ml.On (b)(6) 2017 the patient 2 sample was repeated with an automatic dilution and the free psa result was 3.53 ng/ml.The patient 2 sample was tested using the siemens method and the free psa result was 0.02 ng/ml and the total psa result was 3.24 ng/ml.The customer believed the results from the siemens method.The results were reported outside of the laboratory.There was no allegation of an adverse event.This medwatch will cover the erroneous total psa results on the e 602 module.Refer to medwatch with a1 patient identifier (b)(6) for information on the erroneous free psa results from the e 602 module.

Manufacturer Narrative

The patient samples were 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 is caused by the presence of endogenous interfering substances affecting the epitope or the paratope of the biotinylated anti-psa antibody.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 targeting another epitope.This approach gives a result for the free psa/total psa ratio of <1 in the investigated patient samples.

• 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: 7133053
• MDR Text Key: 96032413
• Report Number: 1823260-2017-03052
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: 26072900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• 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
• Patient Age: 66 YR