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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS+

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SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS+ Back to Search Results
Catalog Number 10379675
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2023
Event Type  malfunction  
Manufacturer Narrative
Siemens has requested the instrument be returned for investigation.The customer has been supplied with a replacement instrument.The cause of this event is unknown.
 
Event Description
The customer reported that their clinitek status+ instrument produced smoke and a burnt smell.They stated that there were no sparks or visible flames.The instrument was immediately unplugged and removed from service.There is no report of injury due to this event.
 
Manufacturer Narrative
Siemens has shown due diligence in requesting the return of the analyzer for investigation.However, the customer has not responded to any requests.Therefore, no investigation can be performed.
 
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Brand Name
CLINITEK STATUS+
Type of Device
CLINITEK STATUS+
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict avenue
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
northern road
chilton industrial estate
sudbury, suffolk CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
felix akinrinola
2 edgewater drive
norwood, MA 02062
MDR Report Key18463354
MDR Text Key332270323
Report Number3002637618-2024-00111
Device Sequence Number1
Product Code JIL
UDI-Device Identifier00630414574639
UDI-Public00630414574639
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/22/2024
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 Health Professional
Device Catalogue Number10379675
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/13/2023
Initial Date FDA Received01/08/2024
Supplement Dates Manufacturer Received01/15/2024
Supplement Dates FDA Received01/22/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage A
Patient Sequence Number1
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