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 Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 1 patient tested for elecsys total psa immunoassay (total psa) and free psa on a cobas e 411 immunoassay analyzer.The erroneous results were not reported outside of the laboratory.This medwatch will cover total psa.Refer to medwatch with patient identifier (b)(6) for information on the free psa erroneous results.The initial total psa result was 0.051 ng/ml.The free psa result was 2.23 ng/ml.On (b)(6) 2017 the sample was repeated and the total psa result was 0.047 ng/ml and the free psa result was 2.18 ng/ml.On (b)(6) 2017 a new sample was obtained and the initial total psa result was 0.111 ng/ml.The free psa result was 4.35 ng/ml.The sample was repeated and the total psa result was 0.016 ng/ml and the free psa result was 4.37 ng/ml.The sample from (b)(6) 2017 was sent to an external laboratory where the total psa and free psa results from a clia method were both approximately 3 ng/ml.These results were believed to be correct and were released to the patient.There was no allegation that an adverse event occurred.The e411 analyzer serial number was not provided.Liquid flow cleaning was last performed on (b)(6) 2017.

Manufacturer Narrative

Preventive maintenance was performed on the instrument on (b)(6) 2017.A cell blank adjustment was performed as the signals were below expectation.

Manufacturer Narrative

The e411 analyzer serial number was (b)(4).Calibration and qc results were acceptable.A specific root cause was not identified.Possible root causes may be related to the rare isotype structure of total psa leading to a low total psa result or an unknown interfering component for total psa; however, since the patient sample is not available, this could not be confirmed.

• 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: 7006655
• MDR Text Key: 92532681
• Report Number: 1823260-2017-02551
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• 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: 199422
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• 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
• Patient Age: 67 YR