MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA IMMUNOASSAY; TOTAL PROSTATE SPECIFIC ANTIGEN TEST

Catalog Number 08791716160

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

There was an allegation of questionable total psa elecsys results from the cobas 8000 - cobas e 602 module.Patient 1 initial result was <0.010 ng/ml and repeat the result was approximately 9 ng/ml.Patient 2 initial result was <0.010 ng/ml and the repeat result was approximately 4 ng/ml.The questionable results were not reported outside of the laboratory.The repeat result was believed correct.

Manufacturer Narrative

The cobas 8000 - cobas e 602 module serial number was (b)(6).The investigation is ongoing.

Manufacturer Narrative

Medwatch field d4 lot no and d4 expiration date were updated.For patient 1, the initial result was actually 0.016 ng/ml with a data flag.For patient 2, the initial result was actually 0.016 ng/ml with a data flag and the repeat result was actually 4.04 ng/ml.The field service engineer adjusted the probe to ensure the probe was centered over the sample tube.The investigation determined the issue was consistent with an improper sample probe adjustment for the new tube type used by the customer.The issue was resolved by the sample probe adjustment for the new sample tube type.

• Brand Name: ELECSYS TOTAL PSA IMMUNOASSAY
• Type of Device: TOTAL PROSTATE SPECIFIC ANTIGEN TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18904165
• MDR Text Key: 337667516
• Report Number: 1823260-2024-00761
• Device Sequence Number: 1
• Product Code: MTF
• UDI-Device Identifier: 07613336166000
• UDI-Public: 07613336166000
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08791716160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1