MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA IMMUNOASSAY; TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Catalog Number 04641655160

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

Sample from the patient was requested for investigation.

Event Description

The initial reporter received questionable elecsys total psa immunoassay and elecsys free psa immunoassay results for one patient from cobas e 411 rack analyzer serial number (b)(4).The total psa result was 0.05 ng/ml and free psa result was 0.149 ng/ml.On (b)(6) 2019 the total psa result was 0.06 ng/ml and free psa result was 0.149 ng/ml.A new sample was drawn from the patient and gave the same results.The questionable results were reported outside of the laboratory.

Manufacturer Narrative

Information was provided that the "wrong sample was delivered" for the previous investigation.Therefore the previously reported investigation results are not valid.A new sample from the patient was submitted for investigation.The testing results suggested the presence of a rare psa-isoform that cannot be completely detected by the usage of the standard total psa elecsys assay.Product labeling for the assay states in rare cases interferences might occur and the impact of the rare psa isoform on the elecsys results.

Manufacturer Narrative

Sample from the patient was submitted for investigation.A free psa result higher than the total psa result could not be confirmed.Further testing showed no evidence for any interfering substance, unspecific signals, or affect the recovery or psa concentration.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TOTAL PSA IMMUNOASSAY
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9457157
• MDR Text Key: 219214824
• Report Number: 1823260-2019-04387
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2020

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: 04641655160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 11/26/2019; 11/26/2019
• Supplement Dates FDA Received: 02/11/2020; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR