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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR CP; IMMUNOASSAY ANALYZER

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SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR CP; IMMUNOASSAY ANALYZER Back to Search Results
Model Number ADVIA CENTAUR CP
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2015
Event Type  malfunction  
Event Description
The customer reported obtaining unflagged out of range quality control results on an advia centaur cp instrument.The customer provided one example.The customer only performs human chorionic gonadotropin (hcg) and progesterone (prg) tests on this system.There are no known reports of patient intervention or adverse health consequences due to unflagged out of range quality control results.
 
Manufacturer Narrative
The customer contacted the siemens customer care center (ccc).A siemens headquarters support center (hsc) specialist reviewed the instrument data.The hsc determined the customer ran quality controls with a sample type of "patient".The hsc determined the customer scheduled quality controls as type "0", indicating a patient sample instead of type "2" which is a quality control.The hsc instructed the customer to run quality controls as type "2".The cause of unflagged out of range quality controls is due to user error: the customer defined and scheduled quality controls as patients instead of quality controls.The instrument is performing within specifications.Further evaluation of the device is not required.
 
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Brand Name
ADVIA CENTAUR CP
Type of Device
IMMUNOASSAY ANALYZER
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict ave
tarrytown NY 10591
Manufacturer (Section G)
STRATEC BIOMEDICAL SWITZERLAND AG
registration #: 3008494306
gewerbestrasse 6
neuhausen am rheinfall 8212,
SZ  
Manufacturer Contact
john nelson
511 benedict ave
tarrytown, NY 10591
9145242530
MDR Report Key4537708
MDR Text Key5519907
Report Number2432235-2015-00090
Device Sequence Number1
Product Code DHA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971418
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Health Professional
Type of Report Initial
Report Date 01/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberADVIA CENTAUR CP
Device Catalogue Number086-A002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2015
Initial Date FDA Received02/24/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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