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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

The customer received questionable total (free + complexed) psa - prostate-specific antigen (tpsa) and free psa results for multiple samples from one patient.The samples were tested on cobas e601 serial number (b)(4).Refer to the medwatch with patient identifier (b)(6) for the total psa assay.On 05/27/2015, the tpsa was 0.32 ng/ml and free psa was 0.42 ng/ml.On (b)(6) 2015, the tpsa was 0.235 ng/ml and free psa was 0.513 ng/ml.The sample was repeated and the tpsa was 0.232 ng/ml and free psa was 0.516 ng/ml.The sample was tested on cobas e601 serial number (b)(4) and the tpsa was 0.219 ng/ml and free psa was 0.354 ng/ml.A second sample drawn (b)(6) 2015 was tested and the tpsa was 0.227 ng/ml and free psa was 0.508 ng/ml.The erroneous results were reported outside the laboratory.The patient was not adversely affected.The free psa reagent expiration date was given as "2016-05".

Manufacturer Narrative

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

Manufacturer Narrative

Sample from the patient was submitted for investigation and the customer's results were confirmed on a cobas (b)(4).No anti-idiotype or (b)(4) interferences were found in the sample.An unknown interfering substance was identified by adding a psa specific antibody with different specificity to the tpsa reagent.This type of interference is described in product labeling.Further investigation was not possible as no sample material remained.

• 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
• 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: 4953349
• MDR Text Key: 6035331
• Report Number: 1823260-2015-03887
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/02/2015

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: ASKU
• Device Lot Number: 183535
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 07/14/2015
• Initial Date FDA Received: 07/30/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 052 YR