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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANALYTICAL E MODULE; IMMUNOCHEMISTRY ANALYZER
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ROCHE DIAGNOSTICS ANALYTICAL E MODULE; IMMUNOCHEMISTRY ANALYZER Back to Search Results
Catalog Number ASKU
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/04/2014
Event Type  malfunction  
Event Description
The customer received a questionable free psa result for one patient sample.The specific date of testing was not provided.The free psa result was 5.20 ng/ml and total psa result was 0.77 ng/ml.The results were reported outside the laboratory.No adverse event was reported.The free psa reagent lot number and expiration date were requested, but were not provided.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.No sample from the patient could be provided for further investigation.
 
Manufacturer Narrative
This event occurred in (b)(6).
 
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Brand Name
ANALYTICAL E MODULE
Type of Device
IMMUNOCHEMISTRY ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250
Manufacturer (Section G)
HITACHI HIGH TECH CORP.
882 ichige hitachinaka
na
ibaraki 6830 5
JA   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key4262667
MDR Text Key5107509
Report Number1823260-2014-09052
Device Sequence Number1
Product Code LTJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K961481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Event Location Laboratory
Date Manufacturer Received11/04/2014
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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