MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FREE PSA; TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA

Catalog Number 03289788190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for the elecsys free psa immunoassay (fpsa) and the elecsys total psa immunoassay (tpsa) on a cobas 8000 e 602 module (e602).The fpsa result was higher than the tpsa result.The same results occur when other blood samples of the patient are tested (the fpsa result is greater than the tpsa result).This medwatch will apply to the fpsa assay.Patient identifier (b)(6) for information related to the tpsa assay.The sample resulted as 4.78 ng/ml for fpsa and 0.327 ng/ml for tpsa.No adverse events were alleged to have occurred with the patient.The e602 analyzer serial number was asked for, but not provided.

Manufacturer Narrative

The patient sample was provided for investigation.The customer's results were confirmed during the investigation.The sample contained an interferent to the tpsa assay.This limitation is covered in product labeling.

• Brand Name: FREE PSA
• Type of Device: TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA
• 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: 6692359
• MDR Text Key: 79526321
• Report Number: 1823260-2017-01402
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P000027
• 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: 07/24/2017

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: 03289788190
• Device Lot Number: 20987700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 06/21/2017
• Supplement Dates FDA Received: 07/24/2017
• 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