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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM 1300 CREATINE KINASE MB (CKMB) ATELLICA IM 1300 CKMB

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM 1300 CREATINE KINASE MB (CKMB) ATELLICA IM 1300 CKMB Back to Search Results
Model Number N/A
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2019
Event Type  malfunction  
Manufacturer Narrative
Siemens healthcare diagnostics is investigating and has requested additional information from the customer. The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. ".
 
Event Description
The customer observed an elevated result with atellica im 1300 creatine kinase mb (ckmb) compared to a result generated with a different lot of atellica im ckmb calibrators. There are no reports that treatment was altered or prescribed or adverse consequences due to the elevated result.
 
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Brand NameATELLICA IM 1300 CREATINE KINASE MB (CKMB)
Type of DeviceATELLICA IM 1300 CKMB
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict avenue
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
333 coney street
east walpole MA 02032
Manufacturer Contact
louise mclaughlin
333 coney street
east walpole, MA 02032
5086604381
MDR Report Key9385331
MDR Text Key208122515
Report Number1219913-2019-00253
Device Sequence Number1
Product Code JHS
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K962126
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 12/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Model NumberN/A
Device Catalogue Number10995530
Device Lot Number52304227
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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