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

Catalog Number	07027966190
Medical Device Problem Codes	High Test Results (2457); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For both e 801 modules, the field service engineer performed system checks with acceptable results.He replaced the syringe seals.He performed calibration, qc, and precision testing with passing results.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys free psa immunoassay and elecsys total psa immunoassay results for one patient tested on a cobas 8000 e 801 module.Prior to patient testing, the customer confirmed qc was acceptable.The patient had a sample collected on (b)(6) 2021 for free psa and total psa testing.On each date of testing, the initial results were reported outside the laboratory.The customer questioned the reported free psa and total psa results.The patient's samples were not repeated due to the samples being discarded.On (b)(6) 2021, the patient's results were free psa 4.240 ng/ml and total psa 1.34 ng/ml.On (b)(6) 2021, the patient's results were free psa 4.810 ng/ml and total psa 1.630 ng/ml.The customer was unsure which e 801 module was used for testing.The e 801 module serial numbers are (b)(4).This medwatch is for total psa.Refer to the medwatch with patient identifier (b)(6) for the free psa assay.
Additional Manufacturer Narrative
The customer's calibration results were acceptable for both free psa and total psa.The customer's qc results, sample pre-analytical details, patient sample, and additional patient information were requested but not available to be provided.The investigation reviewed the system's alarm trace and there were sample clot detection and sample short errors.These are indicators of possible poor sample quality.Based on the available information, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TOTAL PSA IMMUNOASSAY
• Common Device Name: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12167891
• Report Number: 1823260-2021-02026
• Device Sequence Number: 14378779
• Product Code: MTF
• UDI-Device Identifier: 04015630939824
• UDI-Public: 04015630939824
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 07027966190
• Device Lot Number: 52684301
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR