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

Catalog Number 07027320190

Device Problems High Test Results (2457); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2021

Event Type  malfunction  

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 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 free psa.Refer to the medwatch with patient identifier (b)(6) for the total psa assay.

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 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: 12167881
• MDR Text Key: 272160521
• Report Number: 1823260-2021-02025
• Device Sequence Number: 1
• Product Code: MTG
• UDI-Device Identifier: 04015630940011
• UDI-Public: 04015630940011
• Combination Product (y/n): N
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 07027320190
• Device Lot Number: 49579301
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR