Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+ Back to Search Results
Catalog Number 10379675
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2015
Event Type  No Answer Provided  
Event Description
Customer reported that barcode scanner was not coding correctly.Customer explained that when barcode label will be scanned, it will intermittently replace ids with letter h with letter j.Customer stated that they are interfaced with meditech and use qml as middleware.She stated that they have tried to scan flat labels as well as applying label barcode to sample cup and scanning that way and same error occurred.There was no report of injury due to this event.
 
Manufacturer Narrative
Affected barcodes were received and they are in process of investigation.The cause for the event is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key4562485
MDR Text Key5458254
Report Number1217157-2015-00026
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 User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/02/2015
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
Device Catalogue Number10379675
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2015
Initial Date FDA Received03/03/2015
Was Device Evaluated by Manufacturer? No
Patient Sequence Number1
-
-