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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+
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SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+ Back to Search Results
Catalog Number 10379675
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2015
Event Type  No Answer Provided  
Manufacturer Narrative
Customer indicated that they have resolved the issue themselves by performing good internal cleaning (no details provided) to all of their instruments.Customer stated that after the cleaning, all systems were reporting negative results for affected patient sample.Customer indicated that instrument is operational and reporting hcg results as expected.
 
Event Description
Customer reported discordant hcg result on the instrument.
 
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Brand Name
CLINITEK STATUS+
Type of Device
CT STATUS+
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
northern road
chilton industrial estate
sudbury CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key4932518
MDR Text Key24584237
Report Number1217157-2015-00105
Device Sequence Number1
Product Code JIL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032563
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Report Date 06/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number10379675
Was Device Available for Evaluation? No Information
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2015
Was Device Evaluated by Manufacturer? No
Patient Sequence Number1
Patient Age24 YR
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