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.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2021-00414 initial report on (b)(6) 2021.Additional information: 2021-09-10.Siemens concluded investigation for a united states customer observation of an unexpectedly elevated atellica im creatine kinase mb (ckmb) result on a patient.Siemens reviewed the available information to determine probable cause and evaluate for potential product issue.Qc was in range when the sample was tested, indicating this is a sample/patient specific issue.Ck-isoenzyme testing results provided by the customer for this sample were not concordant with the atellica im ckmb result of 15.1 ng/ml (reference interval = 0 - 5.0 ng/ml).The ck-mb fraction was 0%.There was a ck-macro type i band = 13%.Total ck was also elevated with a result of 432 u/l (reference interval = 0 - 200 u/l).It is understood that an elevated ck-mb result was not expected for this patient and while siemens cannot determine the exact cause of the elevated result, the presence of an interfering ck-macro complex in the sample cannot be ruled out.No additional sample was able to be provided by the customer for further investigation.Siemens reviewed atellica im ckmb and advia centaur ckmb complaints historically back to 2015 and there are no similar reports found.The atellica im ckmb assay is traceable to an internal standard manufactured using highly purified material and has no claim to match isoenzyme electrophoresis results.Based on the information provided, no product non-conformance was identified.The customer is operational.No further evaluation of the device is required.In section h6, the investigation finding, and investigation conclusion codes were updated based on the investigation results.

• 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
• MDR Report Key: 12319406
• MDR Text Key: 268027133
• Report Number: 1219913-2021-00414
• Device Sequence Number: 1
• Product Code: JHS
• UDI-Device Identifier: 00630414598581
• UDI-Public: 00630414598581
• Combination Product (y/n): N
• PMA/PMN Number: K962126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

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: Health Professional
• 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
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR