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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER

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ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER Back to Search Results
Model Number E601
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2017
Event Type  malfunction  
Manufacturer Narrative
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
 
Event Description
The customer obtained a questionable low test result for one patient sample using the elecsys ca 19-9 immunoassay (ca 19-9) on the cobas 6000 e 601 module. All results are in units of u/ml. No results were released outside the laboratory. No data flags or alarms occurred with the results. The initial result was 34. 17. The repeat result was 6. 10. On (b)(6) 2017, a new sample was requested with a result of 36. 80. There was no allegation that an adverse event occurred. The ca 19-9 reagent lot number is 193941; the expiration date was 05/2018. Calibration and quality controls were acceptable; therefore, a general reagent problem could be excluded. A specific root cause for this event could not be identified. Additional information was requested for investigation but was not provided. Possible root causes for the non-reproducible low test result were bubbles or foam on the sample or reagent surface, and insufficient pre-analytical handling practices.
 
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Brand NameCOBAS 6000 E 601 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 Key6807475
MDR Text Key83691049
Report Number1823260-2017-01777
Device Sequence Number0
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K060373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 08/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberE601
Device Catalogue Number04745922001
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 Received08/02/2017
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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