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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER

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ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER Back to Search Results
Model Number C501
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2017
Event Type  malfunction  
Manufacturer Narrative
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Based on the provided calibration, qc, and analyzer check data, instrument or reagent problems were ruled out. Since the same sample generated an alarm indicating a clot when tested on another analyzer in the laboratory, a preanalytic issue was suspected.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer received a questionable low ckl creatine kinase result for one patient sample. The initial result was 9 u/l and was reported outside the laboratory. The physician questioned the result because it did not agree with the clinical picture and the previous result of 1939 u/l. The sample was repeated and the result was 1565 u/l. This result was believed to be correct. The patient was not adversely affected. The reagent lot number was 20471501 with an expiration date of 11/30/2017. The customer stated the same sample generated an alarm indicating a clot when tested on another analyzer in the laboratory. The customer did not know if there was a clot in the sample at the time of the event. The field service representative determined the erroneous result was either due to a clot in the sample or the analyzer not detecting the sample was clotted. He checked the analyzer, verified the performance of the rinse mechanism, and checked all probe alignments. He ran a precision check with results well within guidelines.
 
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Brand NameCOBAS 6000 C (501) MODULE
Type of DeviceCLINICAL CHEMISTRY 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 Key6702813
MDR Text Key143933392
Report Number1823260-2017-01446
Device Sequence Number0
Product Code CGS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Medical Technologist
Type of Report Initial,Followup
Report Date 07/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC501
Device Catalogue Number04745914001
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 Received06/27/2017
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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