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 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for the elecsys total psa immunoassay (tpsa) and the elecsys free psa immunoassay (fpsa) on a cobas 6000 e 601 module (e601).The fpsa value was higher than the tpsa value.It was asked, but it is not known if an erroneous result was reported outside of the laboratory.This medwatch will apply to the tpsa assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the fpsa assay.The sample resulted as 0.66 ng/ml when tested for tpsa and resulted as 0.69 ng/ml when tested for fpsa.The sample was repeated for tpsa and the result was 0.66 ng/ml.The patient was not adversely affected.The e601 analyzer serial number was (b)(4).

Manufacturer Narrative

The patient sample was tested for tpsa using a "clia" test method and the result was 0.69 ng/ml.The sample was provided for investigation, where it was tested on an e601 analyzer and an e602 analyzer.When tested on an e601 analyzer on (b)(6) 2017, the sample had a tpsa result of 0.601 ng/ml and an fsa result of 0.660 ng/ml.The sample was repeated on the e601 analyzer on (b)(6) 2017, resulting with a tpsa value of 0.600 ng/ml and a fpsa value of 0.649 ng/ml.When tested on the e602 analyzer on (b)(6) 2017, the sample had a tpsa result of 0.614 ng/ml and a fpsa result of 0.643 ng/ml.The sample was also tested using an outsourced "psa-act"/"acs-cpsa free psa" test method on the advia centaur analyzer, resulting with a value of 0.2 ng/ml.Preliminary investigations determined the issue may be related to the very low psa concentration of the sample.A non-specific reaction was not observed.The serial numbers of the e601 analyzer and e602 analyzer used for investigations were asked for, but not provided.The reagent lot number used on the investigation e601 analyzer was tpsa reagent lot number 135984, with an expiration date of 05/31/2017.The reagent lot number used on the investigation e602 analyzer was tpsa reagent lot number 135984, with an expiration date of 05/31/2017.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.The involved sample could not be made available for further investigations.The customer's observation was duplicated.A general product problem could be excluded.

• 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: 6375893
• MDR Text Key: 69018274
• Report Number: 1823260-2017-00456
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• 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