MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASKU; FREE PROSTATE SPECIFIC ANTIGEN TEST

Model Number ASKU

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's calibration and qc data were requested but not provided.The patient's sample was requested for an investigation, but the patient's sample was not available.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable elecsys total psa and elecsys free psa immunoassay results for one patient tested on a cobas e411 disk serial number (b)(4).The patient¿s total psa and free psa results were not reported outside the laboratory.The patient¿s total psa result was 0.006 ng/ml, and the patient¿s free psa result was 0.087 ng/ml.The total psa and free psa reagent lot numbers and expiration dates were requested but not provided.This medwatch is for free psa.Refer to the medwatch with a1 patient identifier pt-48116 for the total psa assay.

Manufacturer Narrative

Updated fields to medwatch: d2 and g1.

• Brand Name: ASKU
• Type of Device: FREE PROSTATE SPECIFIC ANTIGEN TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10810431
• MDR Text Key: 223619209
• Report Number: 1823260-2020-02822
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• PMA/PMN Number: ASKU
• 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: 11/09/2020

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 Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1