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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
Model Number 10379675
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2022
Event Type  malfunction  
Manufacturer Narrative
Siemens has shown due diligence in attempting to have reagent returned for further investigation however, the customer has not responded.A review of the certificate of analysis for the lot in question showed that the product was performing to specifications at the time of release.The cause of this event is unknown.
 
Event Description
The customer reported a false negative leukocyte result from their clinitek status + instrument compared to repeat giving a result of large which met the clinical picture.There is no report of injury due to this event.
 
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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, CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
tim krauskopf
2 edgewater drive
norwood, MA 02062
6107052212
MDR Report Key13921242
MDR Text Key297909277
Report Number3002637618-2022-00021
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
Report Date 03/25/2022
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 Model Number10379675
Device Catalogue Number10379675
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/02/2022
Initial Date FDA Received03/26/2022
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 Reuse
Patient Sequence Number1
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