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

Catalog Number 07027320190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable elecsys free psa immunoassay results from an investigation sites cobas 8000 e 801 module compared to the clei psa tandem method.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The cobas e801 serial number from the investigation is (b)(4).The investigation is currently ongoing.

Manufacturer Narrative

The control measurement was within range the date of the event.The sample was no longer available for investigation.The measured fpsa or tpsa value of a patient¿s sample can vary depending on the testing procedure used.Therefore, fpsa or tpsa values determined on patient samples by differing testing procedures cannot be directly compared with one another.This is described in the product labeling.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8393893
• MDR Text Key: 137939222
• Report Number: 1823260-2019-00884
• 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: 03/27/2019

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 Expiration Date: 08/31/2019
• Device Catalogue Number: 07027320190
• Device Lot Number: 330860
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1