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 04491734160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

The customer received questionable results for total (free + complexed) prostate specific antigen (tpsa) on one patient that had two samples that were drawn on (b)(6) 2014 and (b)(6) 2014.The physician did not believe the drop in results between (b)(6) 2014 and 01/09/2014 and questioned the results.Based on a digital rectal exam and a consultation with a urologist, there would be no reason to see the drop in values between the two samples.The customer indicated that it was unknown which of the two cobas 6000 e601 instruments the results were generated on.On (b)(6) 2014 at 6:00 am the initial tpsa result was 79.39 ng/ml, which was reported outside of the laboratory.On (b)(6) 2014, the result was confirmed by running two other tubes that were from the same sample draw.The additional tubes resulted 75.74 ng/ml and 81.44 ng/ml respectively.The customer did not believe the reported results to be erroneous.There was no allegation of a death or serious injury.On (b)(6) 2014, a new sample was drawn and was tested for tpsa and generated a result of 39.15 ng/ml.The sample was repeated and generated a result of 38.77 ng/ml.The results for tpsa were reported outside of the laboratory.The customer did not believe the reported results to be erroneous.There was no allegation of a death or serious injury.The customer provided samples for further investigation.The lot number of the tpsa reagent in use was 17127602, with an expiration date of 05/31/2014.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.(b)(6).

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

Patient samples were provided for investigation.The tpsa results measured on the cobas 6000 e601 instrument were verified on a centaur system.

Manufacturer Narrative

The investigation confirmed the customer's tpsa and fpsa results.There was no indication of (b)(4) interference.However, there were signs of an interfering substance in the samples drawn on (b)(6) 2014 which might be responsible for the increased psa antigen recovery.The sample drawn on (b)(6) 2014, showed a somewhat non-linear behavior, which might also indicate a presence of an interfering substance.The nature of the interfering substances is unknown.The potential for interference is documented in the product labeling.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3606067
• MDR Text Key: 4066752
• Report Number: 1823260-2014-00733
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/04/2014

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 Expiration Date: 05/31/2014
• Device Catalogue Number: 04491734160
• Device Lot Number: 17127602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 02/04/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2014; 03/19/2014; 04/04/2014
• 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
• Treatment: PLEASE SEE THE ATTACHMENT TO THE MEDWATCH
• Patient Age: 074 YR