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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CREATINE KINASE MB (CKMB) CKMB IMMONOASSAY

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CREATINE KINASE MB (CKMB) CKMB IMMONOASSAY Back to Search Results
Model Number N/A
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
Event Type  malfunction  
Manufacturer Narrative
Calibration and qc results were acceptable. All frozen specimens are mixed well and centrifuged after thaw and prior to analysis. There was no hemolysis, icterus or lipemia observed. The customer stated that the electrophoresis plate and band that reads 13% is directly following the mm band and clearly not migrated to the mb location. The customer is requesting whether there may be interference/lack of specificity in the presence of ck macro with the atellica im ckmb assay. The interpretation of results section in the instructions for use (ifu) states: "serial sampling at the appropriate time intervals will result in the typical rise and fall pattern of ck-mb levels in patients experiencing myocardial infarction. Elevated ck-mb levels may be related to non-ami events such as congestive heart failure, strenuous exercise, or trauma. These events should be considered when interpreting ck-mb results. " "results of this assay should always be interpreted in conjunction with the patient's medica history, clinical presentation, and other findings. " the limitations section in the ifu states: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay is designed to minimize interference from heterophilic antibodies. 16,17 additional information may be required for diagnosis. " siemens healthcare diagnostics is investigating.
 
Event Description
A customer observed an elevated atellica im creatine kinase mb (ckmb) immunoassay result compared to low ck isoenzyme electrophoresis results. The initial result was reported and questioned by the physician. The physician believes there is an abnormal high ckmb by immunoassay compared to ck isoenzyme by electrophoresis. The sample was not retested using atellica im creatine kinase mb (ckmb). There are no known reports of patient intervention or adverse health consequences due to the elevated atellica im ckmb result.
 
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Brand NameATELLICA IM CREATINE KINASE MB (CKMB)
Type of DeviceCKMB IMMONOASSAY
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict avenue
tarrytown NY 10591 5097
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
333 coney street
east walpole MA 02032
Manufacturer Contact
stacy loukos
333 coney street
east walpole, MA 02032
3392064073
MDR Report Key12319406
MDR Text Key268027133
Report Number1219913-2021-00414
Device Sequence Number1
Product Code JHS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962126
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/27/2022
Device Model NumberN/A
Device Catalogue Number10995531
Device Lot Number249
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 Received09/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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