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

Catalog Number 08791686190

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

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

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e411 analyzer is (b)(6).The customer's calibration signals were within expected ranges for the first calibrator level but were lower than expected for the second calibrator level.Quality controls were ok on the day of the event.Upon initial investigation, it was determined the measuring cell has not been replaced since on (b)(6)2021.Measuring cells are recommended to be changed after 70000 cycles or 18 months, whichever comes first.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with elecsys total psa on a cobas e411 disk.The first patient sample initially resulted in a total psa value of < 0.006 ng/ml with a data flag.Since the result was below the measuring range, the customer suspected the result may have been incorrect, so the sample was repeated.The sample was repeated twice, resulting in values of 5.50 ng/ml and 5.33 ng/ml.The 5.33 ng/ml value was deemed correct.The second patient sample initially resulted in a total psa value of 0.068 ng/ml.The value was accompanied by a data flag indicating carryover.The sample was repeated, resulting in a value of 3.29 ng/ml.The 3.29 ng/ml value was deemed correct.

Manufacturer Narrative

The field service engineer replaced the measuring cell and the liquid level detection printed circuit board assembly.A joint was also replaced.The mixer was producing bubbles in the reagent, so it was replaced.No further issues occurred since these actions.The investigation determined the issue was resolved by the mixer replacement.

• Brand Name: ELECSYS TOTAL PSA
• Type of Device: TOTAL PROSTATE SPECIFIC ANTIGEN
• 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: 18580163
• MDR Text Key: 333733440
• Report Number: 1823260-2024-00225
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): Y
• Reporter Country Code: RO
• PMA/PMN Number: P990056
• 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
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08791686190
• Device Lot Number: 70823705
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• 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
• Patient Age: 68 YR
• Patient Sex: Male