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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER
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ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER Back to Search Results
Model Number E801
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2020
Event Type  malfunction  
Manufacturer Narrative
The qc data gave no indication for a performance issue of reagent or instrument.The investigation is ongoing.This event occurred in (b)(6).
 
Event Description
The initial reporter received questionable elecsys vitamin d assay gen 2 results for one patient from the cobas e 801 module.The initial result was 95.1 ng/ml and the repeat result was >100 ng/ml.With a 1:2 dilution, the result was 160 ng/ml and was reported outside of the laboratory.The reagent lot number was 42497802 with an expiration date of 31-aug-2020.
 
Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.The field service representative replaced the measuring cell and ran performance testing which was acceptable.
 
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Brand Name
COBAS 8000 E 801 MODULE
Type of Device
IMMUNOCHEMISTRY ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key9635642
MDR Text Key219782509
Report Number1823260-2020-00206
Device Sequence Number1
Product Code MRG
Combination Product (y/n)N
PMA/PMN Number
K060373
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 02/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberE801
Device Catalogue Number07682913001
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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