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

Catalog Number 08828601190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas e411 rack is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received a questionable free psa elecsys result from one patient sample tested on the cobas e411 rack.The reporter complained that the free psa result was greater than the total psa result.The patient sample was then referred to another laboratory that also uses the electrochemiluminescence immunoassay (eclia) laboratory method.The total psa result from the analyzer was 0.985 ng/ml.The initial free psa result from the analyzer was 2.32 ng/ml.The repeat free psa result from the other laboratory's analyzer was 0.25 ng/ml.The repeat result was deemed correct because the free psa was lower than the total psa result and fit the patient's clinical history.

Manufacturer Narrative

Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The field service engineer (fse) inspected the analyzer and found the sipper nozzle bent.He then replaced this part.The investigation determined the event was caused by the bent sipper nozzle.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS 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
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18658133
• MDR Text Key: 334732231
• Report Number: 1823260-2024-00348
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): Y
• Reporter Country Code: PE
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 08828601190
• Device Lot Number: 72616901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1