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

Catalog Number 08828610190

Device Problem Incorrect Measurement (1383)

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

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique device identifier (udi) (b)(4).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys free psa immunoassay and elecsys total psa immunoassay results for one patient tested on a cobas 8000 e 801 module.The patient's elecsys free psa immunoassay results were greater than the patient's elecsys total psa immunoassay results.The patient's initial results were not reported outside the laboratory.The customer provided the samples for additional testing.The samples were tested on a cobas 8000 e 801 module, cobas e 411 immunoassay analyzer, and an outsourced cleia analyzer.The customer's e 801 module serial number was requested but not provided.

Manufacturer Narrative

The customer provided the patient's sample for an investigation.The investigation confirmed the customer's elecsys free psa immunoassay and elecsys total psa immunoassay results.The investigation discovered the reported results were below the stated measuring ranges.As stated in the elecsys total psa immunoassay method sheet, "measuring range 0.006-100 ng/ml." as stated in the elecsys free psa immunoassay method sheet, "measuring range 0.01-50 ng/ml." upon investigation of the patient sample, no interferent against a component of the reagent was discovered.The customer's calibration and qc results, system alarm trace, and sample pre-analytical details were requested but not provided.The investigation did not identify a product problem.

• Brand Name: FREE 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
• MDR Report Key: 11744120
• MDR Text Key: 270209767
• Report Number: 1823260-2021-01277
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 08828610190
• Device Lot Number: 473312
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 95 YR