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

Catalog Number 03289788190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The customer complained of questionable elecsys total psa immunoassay and elecsys free psa immunoassay results for 1 patient tested on a cobas e 411 immunoassay analyzer.This medwatch will cover the freelpsa.Refer to the medwatch with patient "idetifier" (b)(6) for information of totalpsa.The initial freepsa result was 0.293 ng/ml.The initial totalpsa result was 0.030 ng/ml.On (b)(6) 2019 the same patient sample was tested with a freepsa result of 0.250 ng/ml.On (b)(6) 2019 the same patient sample was tested with a totalpsa result of 0.030 ng/ml.The erroneous results were not reported outside of the laboratory.There was no allegation of an adverse event.The cobas e411 serial number was (b)(4).The investigation is currently ongoing.

Manufacturer Narrative

On (b)(6) 2019, the totalpsa result was 0.038 mg/ml.Qc data was not provided for the day of the event.The customer is not completing qc once every 24 hours as recommended in the product labeling.The customer provided two aliquots of patient sample for investigation.The investigation was unable to confirm the incorrect result for free psa and total psa.With free psa recovering as 0.197 and 0.214 ng/ml and total psa recovering as 0.634 and 0.770 ng/ml the investigation did not find an interfering substance, or the presence an anti-psa-antiobody that might cause the false results.A general product problem is excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: FREE PSA
• 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: 8281691
• MDR Text Key: 134493998
• Report Number: 1823260-2019-00305
• 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: 03/12/2019

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 Catalogue Number: 03289788190
• Device Lot Number: 330814
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1