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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASKU; FREE PROSTATE SPECIFIC ANTIGEN TEST

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ROCHE DIAGNOSTICS ASKU; FREE PROSTATE SPECIFIC ANTIGEN TEST Back to Search Results
Model Number ASKU
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).The customer's calibration and qc data were requested but not provided.The patient's sample was requested for an investigation, but the patient's sample was not available.The investigation did not identify a product problem.The cause of the event could not be determined.
 
Event Description
The initial reporter received questionable elecsys total psa and elecsys free psa immunoassay results for one patient tested on a cobas e411 disk serial number (b)(4).The patient¿s total psa and free psa results were not reported outside the laboratory.The patient¿s total psa result was 0.006 ng/ml, and the patient¿s free psa result was 0.087 ng/ml.The total psa and free psa reagent lot numbers and expiration dates were requested but not provided.This medwatch is for free psa.Refer to the medwatch with a1 patient identifier pt-48116 for the total psa assay.
 
Manufacturer Narrative
Updated fields to medwatch: d2 and g1.
 
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Brand Name
ASKU
Type of Device
FREE PROSTATE SPECIFIC ANTIGEN TEST
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key10810431
MDR Text Key223619209
Report Number1823260-2020-02822
Device Sequence Number1
Product Code MTG
Combination Product (y/n)N
PMA/PMN Number
ASKU
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 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberASKU
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/20/2020
Initial Date FDA Received11/09/2020
Supplement Dates Manufacturer Received10/20/2020
Supplement Dates FDA Received11/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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