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

Catalog Number 08791732190

Device Problem Incorrect Measurement (1383)

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

Event Date 09/27/2021

Event Type  malfunction  

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 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 total psa.Refer to medwatch with patient identifier (b)(6) for information on the free 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: TOTAL PSA ELECSYS E2G 300 V2
• Type of Device: 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: 12666991
• MDR Text Key: 277712051
• Report Number: 1823260-2021-03072
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 08791732190
• Device Lot Number: 49236103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1