• 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 PRODUCTS, LIMITED IMMULITE 2000 XPI - CMB

  • 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 PRODUCTS, LIMITED IMMULITE 2000 XPI - CMB Back to Search Results
Model Number IMMULITE 2000 XPI - CMB
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2019
Event Type  malfunction  
Manufacturer Narrative
The customer contacted siemens customer care center (ccc). Siemens headquarters support center (hsc) is reviewing the provided results, the instrument files, and the error logs. The cause for the discordant, falsely elevated cmb sample result is unknown. Siemens is investigating the issue. Mdr 2432235-2019-00310 was filed for the same issue.
 
Event Description
One discordant, falsely elevated creatine kinase isoenzyme - mb (cmb) result was obtained on immulite 2000 xpi instrument. The initial result was not reported to the physician(s). The same sample was repeated using the same immulite 2000 xpi instrument. The repeat result was considered correct and reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated cmb result.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameIMMULITE 2000 XPI - CMB
Type of DeviceIMMULITE 2000 XPI - CMB
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
glyn rhonwy
llanberis, LL55 4EL
EI LL55 4EL
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
glyn rhonwy
uk registration #: 3002806944
llanberis, LL55 4EL
UK LL55 4EL
Manufacturer Contact
mardochee timolien
511 benedict avenue
tarrytown, NY 10591
9145242503
MDR Report Key8967185
MDR Text Key216709589
Report Number2432235-2019-00311
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K004002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberIMMULITE 2000 XPI - CMB
Device Catalogue Number10381033
Device Lot Number253
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-