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 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).(b)(4).

Event Description

The customer complained of a possible interference for 1 patient when tested for elecsys free psa immunoassay on a cobas 6000 e 601 module compared to the patient's elecsys total psa immunoassay results.The customer provided three separate incidents where the patient's free psa values were higher than their total psa results.This medwatch will cover the free psa data.Please refer to the medwatch with patient identifier (b)(6) for data on the total psa.On (b)(6) 2018 the free psa result was 0.78 ng/ml with a total psa result of 0.11 ng/ml.On (b)(6) 2018 the free psa result was 0.61 ng/ml with a total psa result of 0.12 ng/ml.On (b)(6) 2018 the free psa result was 0.51 ng/ml with a total psa result of 0.13 ng/ml.It was only provided that the results from (b)(6) 2018 were released outside of the laboratory.There was no allegation of any adverse events.The only free psa and total psa reagent lot information provided was for the results obtained on (b)(6) 2018.The cobas e602 used for the (b)(6) 2018 results was 26c2-11.The investigation showed that the calibration and qc data that was provided was acceptable.On the day of the (b)(6) 2018 measurements, there was no qc testing performed.The customer provided the patient sample from (b)(6) 2018 for further investigation.The investigation is currently ongoing.

Manufacturer Narrative

The free psa reagent lot was 293436, with an expiration date of 30-april-2019.Calibration data for free psa was acceptable.Qc recovery was within the specified ranges.The sample was tested on a roche analyzer and on a competitor analyzer at an external laboratory for investigation.The customer¿s results were confirmed.The investigation results are consistent with the presence of an interferent.This interference is documented in product labeling.

• 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: 8004050
• MDR Text Key: 126239652
• Report Number: 1823260-2018-03824
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 03289788190
• Device Lot Number: 293436
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/05/2018
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: 10/05/2018
• Supplement Dates FDA Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR