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

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.

• Brand Name: ATELLICA IM CREATINE KINASE MB (CKMB)
• Type of Device: CKMB 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 Key: 12319406
• MDR Text Key: 268027133
• Report Number: 1219913-2021-00414
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962126
• Number of Events Reported: 1
• 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 Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/27/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995531
• Device Lot Number: 249
• 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 Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial