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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER

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ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER Back to Search Results
Model Number E602
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2017
Event Type  malfunction  
Manufacturer Narrative
A specific root cause could not be determined. Typical causes for this type of event include issues with sample quality or insufficient maintenance of the analyzer. The provided calibration and qc data did not indicate a general issue with the analyzer, reagent, calibrator, or controls.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer received a questionable low elecsys ca 19-9 immunoassay result for one patient sample. The initial result was 3 u/ml and was reported to the physician. As the patient had a previous ca 19-9 result from (b)(6) 2017 of 11820 u/ml, the physician questioned the reported result and requested the sample be repeated. The first repeat result was 41. 77 u/ml. The laboratory then repeated the sample again with results of 10885 u/ml and 10505 u/ml. The patient had a new sample drawn on (b)(6) 2017 and the result was 11130 u/ml. The result of 10885 u/ml was believed to be correct. The patient was not adversely affected. The reagent lot number was 19394101 with an expiration date of 5/31/2018. The field service representative found there was possibly an issue with the sample or sample volume. He checked the sample and reagent flowpaths, pinch tubing, and reagent delivery. He ran performance testing and qc.
 
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Brand NameCOBAS 8000 E 602 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 Key6812792
MDR Text Key246315074
Report Number1823260-2017-01798
Device Sequence Number0
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberE602
Device Catalogue Number05990378001
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 Received08/04/2017
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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