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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FREE PSA ELECSYS E2G 300 V2; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
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ROCHE DIAGNOSTICS FREE PSA ELECSYS E2G 300 V2; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS Back to Search Results
Catalog Number 08828610190
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
The patient sample was provided for investigation and the results obtained by the customer could be reproduced.It was determined the sample contained evidence of endogenous interfering substance(s) that would considerably decrease the recovery of total psa.Due to the limited sample volume, the nature of the interfering substance(s) could not be investigated in more detail.A psa isoform which can not be completely detected by the elecsys total psa assay was not found in the sample.The investigation could not identify a product problem.The cause of the event could not be determined.
 
Event Description
The initial reporter stated they received questionable results for one patient sample tested with the elecsys total psa immunoassay and the elecsys free psa immunoassay on a cobas 8000 e 801 module.The free psa value was greater than the total psa value.No incorrect results were reported outside of the laboratory.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 sample was tested on the e 801, resulting in a total psa value of 4.87 ug/l and a free psa value of 6.71 ug/l.The sample was treated with human anti-mouse antibodies and repeated on the e 801, resulting in a total psa value of 4.95 ug/l and a free psa value of 6.82 ug/l.The sample was tested on a siemens analyzer, resulting in a total psa value of 5.4 ug/l and a free psa value of 0.5 ug/l.The sample was also tested on a beckman analyzer, resulting in a total psa value of 0.4 ug/l and a free psa value of 0.7 ug/l.The serial number of the e 801 analyzer is (b)(4).
 
Manufacturer Narrative
Medwatch field d4.Udi number (b)(4).
 
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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 Key11475686
MDR Text Key246062602
Report Number1823260-2021-00769
Device Sequence Number1
Product Code LTJ
Combination Product (y/n)N
PMA/PMN Number
P000027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Catalogue Number08828610190
Device Lot Number47331201
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TAMSULOSIN.
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