MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PSA ELECSYS E2G; TOTAL PROSTATE SPECIFIC ANTIGEN TEST

Catalog Number 08791732214

Device Problem Incorrect Measurement (1383)

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

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer's serial number was not provided.The sample was requested for investigation.The investigation is ongoing.

Event Description

There was an allegation of questionable free psa elecsys e2g and total psa elecsys e2g results for 1 patient sample on a cobas e 801 analytical unit.Total psa results: the initial result was 0.19 ng/ml.The sample was repeated on another analyzer and the result was 0.18 ng/ml.Free psa results: the initial result was 2.98 ng/ml and the repeated result was 3.00 ng/ml.The sample was retested on another analyzer and the result was 2.97 ng/ml.The sample was also tested using another method (alinity abbot) and the total psa result was 0.297 ng/ml.Free psa was not measured using the abbot method.This medwatch will apply to the total psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the free psa assay.

Manufacturer Narrative

Medwatch field a3 gender was updated.The last free psa calibration (on unit 1) before the date of the event was 12-nov-2023 and the results were below expectations.The last free psa calibration (on unit 2) before the date of the event was 26-nov-2023 and the results were below expectations.The free psa qc on both units was acceptable.The last total psa calibration (on unit 1) before the date of the event was 06-dec-2023 and the results were below expectations.The last total psa calibration (on unit 2) was on the date of the event and level 1 was within expectations and level 2 was below expectations.The total psa qc on both units was acceptable.The customer's preanalytical checklist was reviewed.The sample was centrifuged for 5 minutes at 1500g.Most commonly used manufacturers advise the customers to centrifuge serum tubes at = 1300 g for 10 minutes at 18-25°c.The sample was received for investigation.The customer's results were confirmed: free psa: 2.69 ng/ml total psa: 0.172 ng/ml.The sample underwent interference testing.No interference was identified for free psa.An interference was identified for total psa.The results obtained during the investigation suggest the presence of a seldom psa-isoform that cannot be completely detected by the usage of the standard total psa elecsys assay.This interference is covered in product labeling: "it is known that in rare cases psa isoforms do exist which may be measured differently by different psa tests.Findings of this kind have occasionally been reported for psa tests from various manufacturers." the free psa result is considered to be correct.The investigation did not identify a product problem.The reagent performs within specification.A general reagent issue can be excluded.

• Brand Name: TOTAL PSA ELECSYS E2G
• 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: 18869243
• MDR Text Key: 337359473
• Report Number: 1823260-2024-00714
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08791732214
• Device Lot Number: 73160701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• 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 Sex: Male