MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA IMMUNOASSAY; TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Catalog Number 07027966190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Calibration was acceptable.Qc was requested but not provided.The customer did not use the required rack adapters for 13 mm diameter tubes.The patient's sample was requested for investigation, but no sample was available at the customer's site.Based on the available data, the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable free psa and elecsys total psa immunoassay results for one patient tested on a cobas 6000 e 601 module serial number (b)(4).The initial results were reported outside the laboratory.The clinician questioned the initial results and requested the sample to be repeated for confirmation.On (b)(6) 2020, the initial free psa result was 1.11 ng/ml and the total psa result was 0.746 ng/ml.On (b)(6) 2020, the repeat free psa result was 0.097 ng/ml and the total psa result was 0.511 ng/ml.This medwatch is for total psa.Refer to the medwatch with patient identifier (b)(6) for the free psa assay.

• Brand Name: ELECSYS TOTAL PSA IMMUNOASSAY
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• 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: 10245993
• MDR Text Key: 199339171
• Report Number: 1823260-2020-01635
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027966190
• Device Lot Number: 419341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1