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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FREE PSA IMMUNOASSAY V3; FREE PROSTATE-SPECIFIC ANTIGEN
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ROCHE DIAGNOSTICS ELECSYS FREE PSA IMMUNOASSAY V3; FREE PROSTATE-SPECIFIC ANTIGEN Back to Search Results
Catalog Number ASKU
Device Problems Incorrect Measurement (1383); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2022
Event Type  malfunction  
Manufacturer Narrative
The customer used a new reagent and calibrator for total psa and now everything is ok.
 
Event Description
The initial reporter stated they received questionable results for four patients tested with the elecsys total psa immunoassay ver.3 and the elecsys free psa immunoassay on a cobas e 411 immunoassay analyzer.The free psa values were greater than the total psa values.No incorrect results were reported outside of the laboratory.The customer noted the issue occurs only for post surgery patients.Healthy patient results are ok.This medwatch will apply to the free psa assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the total psa assay.The first sample resulted in a total psa value of < 0.006 ng/ml when tested on the e411 analyzer and resulted in a value of 0.270 when tested on a siemens analyzer.This sample resulted in a free psa value of 0.02 ng/ml when tested on the e411 analyzer and resulted in a value of 0.089 ng/ml when tested on a siemens analyzer.The second sample resulted in a total psa value of < 0.006 ng/ml when tested on the e411 analyzer and resulted in a value of 0.092 when tested on a siemens analyzer.This sample resulted in a free psa value of 0.08 ng/ml when tested on the e411 analyzer and resulted in a value of 0.07 ng/ml when tested on a siemens analyzer.On (b)(6) 2022, the third sample resulted in a total psa value of 0.104 ng/ml when tested on the e411 analyzer and resulted in a value of 0.425 when tested on a siemens analyzer.This sample resulted in a free psa value of 0.209 ng/ml when tested on the e411 analyzer and resulted in a value of 0.177 ng/ml when tested on a siemens analyzer.On (b)(6) 2022, the fourth sample resulted in a total psa value of < 0.006 ng/ml when tested on the e411 analyzer and resulted in a value of 0.177 when tested on a siemens analyzer.This sample resulted in a free psa value of 0.231 ng/ml when tested on the e411 analyzer and resulted in a value of 0.209 ng/ml when tested on a siemens analyzer.The serial number of the e411 analyzer is (b)(4).
 
Manufacturer Narrative
The last free psa and total psa calibrations on (b)(6)-2022 had lower than expected signals for the second calibrator level.Alarm trace data was provided, but did not cover the day of the event.There were many alarms indicating that cleaning maintenance needed to be performed.The customer replaced the reagent pack and calibrator material.Calibration and control were within range.No further issues occurred after this action.The investigation could not identify a product problem.The cause of the event could not be determined.
 
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Brand Name
ELECSYS FREE PSA IMMUNOASSAY V3
Type of Device
FREE PROSTATE-SPECIFIC ANTIGEN
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
amy nelson
9115 hague road
na
indianapolis, IN 46250
3174767531
MDR Report Key15229195
MDR Text Key303323204
Report Number1823260-2022-02450
Device Sequence Number1
Product Code LTJ
Combination Product (y/n)N
Reporter Country CodeBK
PMA/PMN Number
P000027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASKU
Device Lot Number546160
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/22/2022
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 Number1
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