MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA IMMUNOASSAY; TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED)

Catalog Number 04491734190

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).Medwatch field, the full common device name was provided as "total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer.".

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys total psa immunoassay (tpsa) and elecsys free psa immunoassay (fpsa) on a cobas 6000 e 601 module (e601).The patient was at the site for a follow up visit after having a prostatectomy.The sample resulted with a tpsa value of 0.003 ng/ml accompanied by a data flag and a fpsa value of 0.13 ng/ml.Both tests were repeated and the results could be duplicated.No specific data was provided.No erroneous results were reported outside of the laboratory.No adverse events were alleged to have occurred with the patient.The serial number of the e601 analyzer was asked for, but not provided.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.

Manufacturer Narrative

The correct fpsa value of the sample was 0.124 ng/ml.The sample also had the following additional test data on (b)(4) 2018: a-tg = < 10.00 ui/ml, vitd-t = 16.04 ng/ml.The serial number of the e601 analyzer was (b)(4).A sample from the patient was provided for investigation.Investigations were unable to duplicate the fpsa value measured by the customer.The tpsa value was duplicated.There was no remaining volume of the sample available for further investigations.The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS TOTAL PSA IMMUNOASSAY
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED)
• 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: 7182030
• MDR Text Key: 96965079
• Report Number: 1823260-2018-00128
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

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: 04491734190
• Device Lot Number: 260729
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 01/03/2018
• Supplement Dates FDA Received: 02/16/2018
• 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