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 sample was requested for investigation, however, the sample has been discarded by the customer.As no sample was available for investigation, the cause of the event could not be determined.The investigation did not identify a product problem.
Event or Problem Description
The initial reporter questioned results for 1 patient sample tested for total psa elecsys e2g 300 v2 (total psa) and free psa elecsys e2g 300 v2 (free 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.The initial free psa result was 0.0259 ng/ml and the initial total psa result was 0.0067 ng/ml.The initial results were reported outside of the laboratory where the clinicians questioned the results as a free psa result greater than a total psa was believed to be "impossible." on (b)(6) 2021 the sample was repeated with a free psa result of 0.0268 ng/ml and a total psa result of 0.00908 ng/ml.Qc was acceptable, however, calibration had "expired." the customer recalibrated both assays and ran acceptable qc.The sample was repeated again and the free psa result was 0.0100 ng/ml with a data flag and the total psa result was 0.00600 with a data flag ng/ml.The e801 analyzer serial number was (b)(4).

• 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
• MDR Report Key: 12666935
• Report Number: 1823260-2021-03071
• Device Sequence Number: 4211634
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: 06/30/2022
• Device Catalogue Number: 08828610190
• Device Lot Number: 52820902
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1