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

Catalog Number ASKU

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

The country of origin is (b)(6).The sample has been requested for return.

Event Description

The initial reporter received questionable elecsys free psa immunoassay (fpsa) results, for 2 samples, from the cobas 8000 e 801 module serial number (b)(4).This mdr will cover the fpsa reagent.Refer to the mdr with patient identifier = (b)(6) for the elecsys total psa immunoassay (tpsa) reagent.Sample 1: (e801 module results), tpsa: 0.150 ng/ml, fpsa: 2.39 ng/ml.(clia method results), tpsa: 1.17 ng/ml, fpsa: 0.05 ng/ml.Sample 2: (collected on 04-dec-2019, e801 module results), tpsa: 0.198 ng/ml, fpsa: 3.08 ng/ml.The questionable results were not reported outside the laboratory.

Manufacturer Narrative

The patient samples were provided for investigation.Investigations of the patient sample could reproduce the customer's measurements.Further investigations of the sample showed no evidence of nonspecific signals being generated when measuring the sample for free psa.The investigation could not identify a product problem for free psa.The cause of the event could not be determined investigations of the sample determined there is evidence of an interfering substance or substances present in the sample, causing a considerable decrease in the recovery of total psa.An anti-psa antibody with different specificity was added to the sample and this showed a significant increase in total psa concentration.This would also suggest the presence of a psa isoform that cannot be completely detected by the usage of the standard elecsys total psa assay.Product labeling for total psa states: " in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.It is known that in rare cases psa isoforms do exist which may be measured differently by different psa tests.Findings of this kind have occasionally been reported for psa tests from various manufacturers.".

• Brand Name: ELECSYS FREE PSA IMMUNOASSAY
• 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
• MDR Report Key: 9529938
• MDR Text Key: 219774351
• Report Number: 1823260-2019-04567
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BUSONID.; INDAPEN SR.; LOSARTANA POTÁSSICA.; PREDINISONA.; SINOT.
• Patient Age: 64 YR