MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FREE PSA ELECSYS E2G 300 V2; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Catalog Number	08828610190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The samples were requested for investigation.
Event or Problem Description
The initial reporter questioned results for 2 patient samples tested for free psa elecsys e2g 300 v2 (free psa) and total psa elecsys e2g 300 v2 (total psa) on a cobas e801 analytical unit.This medwatch will cover free psa.Refer to medwatch with patient identifier (b)(6) for information on the total psa results.Patient 1 total psa result from the e801 analyzer was 0.0423 ng/ml and the free psa result was 0.0724 ng/ml.These results were reported outside of the laboratory.The sample was repeated on the e801 analyzer with a total psa result of 0.043 ng/ml and a free psa result of 0.0734 ng/ml.The sample was repeated again on the e801 analyzer with a total psa result of 0.0422 ng/ml and a free psa result of 0.0751 ng/ml.On (b)(6) 2021 the sample for patient 1 was tested by the mindray method with a total psa result of 0.025 ng/ml and a free psa result of 0.038 ng/ml.On (b)(6) 2021 the sample for patient 1 was tested by the abbott method with a total psa result of 0.04 ng/ml and a free psa result of 0.026 ng/ml.On (b)(6) 2021 patient 2 initial total psa result was 0.17 ng/ml and the free psa result was 0.901 ng/ml.The sample for patient 2 was tested by the mindray method and the total psa result was 0.179 ng/ml and the free psa result was 0.088 ng/ml.The e801 analyzer serial number was (b)(4).
Additional Manufacturer Narrative
Three samples were submitted for investigation and tested on an e801 module.It is not clear if all 3 samples were for patient 1 or patient 2 or if they were for both patient 1 and 2.The incorrect results for free psa and total psa alleged by the customer were confirmed during the investigation.For 2 samples, there was not enough sample left for further investigation.One sample (a sample from patient 2) was investigated further through dilution and spiking experiments.The investigation determined the presence of a rare interference against a component of the reagent causing the low results for both free psa and total psa.The investigation did not identify a product problem.Both assays perform within specification.

• Brand Name: FREE PSA ELECSYS E2G 300 V2
• Common Device Name: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12674199
• Report Number: 1823260-2021-03079
• Device Sequence Number: 11894766
• Product Code: LTJ
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 08828610190
• Device Lot Number: 52820901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1 - BICALUTAMIDE CAPSULES; PATIENT 1 - LEUPRORELIN ACETATE MICROSPHERES INJEC; PATIENT 1 - BICALUTAMIDE CAPSULES; PATIENT 1 - LEUPRORELIN ACETATE MICROSPHERES INJEC
• Patient Age: 70 YR
• Patient Sex: Male