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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 12/19/2019
Event Type  malfunction  
Manufacturer Narrative
The customer was not following the required calibration frequency stated in product labeling for the tsh assay. The qc data gave no indication for a performance issue of reagent or instrument. The investigation did not identify a product problem. The cause of the event could not be determined. This event occurred in (b)(6).
 
Event Description
The initial reporter received questionable elecsys ft4 iii assay and elecsys tsh assay results for one patient from the cobas e 801 module. The initial ft4 result was 4. 18 pmol/l and initial tsh result was 0. 05 iu/ml. On (b)(6) 2019, the repeat ft4 result was 15. 7 pmol/l and repeat tsh result was 0. 596 iu/ml. The repeat results were deemed to be correct because they have compared this results to abbott system. No specific data was provided. The repeat results were reported outside of the laboratory. The ft4 reagent lot number was 43284400 with an expiration date of 30-sep-2020. The tsh reagent lot number was 41623300 with an expiration date of 31-oct-2020.
 
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Brand NameCOBAS 8000 E 801 MODULE
Type of DeviceIMMUNOCHEMISTRY ANALYZER
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
HITACHI HIGH TECH CORP.
882 ichige hitachinaka
na
ibaraki 312-8 504
JA 312-8504
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key9558866
MDR Text Key219779921
Report Number1823260-2020-00077
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
K060373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberE801
Device Catalogue Number07682913001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2019
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
Type of Device Usage

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