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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. CLINITEK STATUS; CT STATUS
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SIEMENS HEALTHCARE DIAGNOSTICS, INC. CLINITEK STATUS; CT STATUS Back to Search Results
Catalog Number 10332185
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2014
Event Type  malfunction  
Event Description
Customer reported the misidentification of multistix 10 sg as multistix pro 10 lb on the instrument with a pyridium sample.There was no report of injury for this event.
 
Manufacturer Narrative
Customer has been informed not to run abnormally colored urine samples on instrument particularly pyruvate/pyridium samples.As per reagent ifu: substances that cause abnormal urine color may affect the readability of test pads on urinalysis reagent strips.These substances include visible levels of blood or bilirubin and drugs containing dyes (e.G., pyridium, azo gantrisin, azo gantanol), nitrofurantoin (macrodantin, furadantin), or riboflavin.Customer has been sent software version 2.4 which will trigger error code (e50) instead of misidentification.
 
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Brand Name
CLINITEK STATUS
Type of Device
CT STATUS
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict ave
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS
manufacturing ltd.
northern road
sudbury, suffolk CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key4012085
MDR Text Key15124859
Report Number1217157-2014-00115
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number10332185
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/29/2014
Initial Date FDA Received08/15/2014
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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