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

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Mdr 1219913-2019-00253 was filed on november 27, 2019 reporting 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.November 27, 2019 - additional information: the customer confirmed that the samples were frozen within 48 hours.Siemens reviewed the information provided to determine probable cause.The customers qc ((b)(6) 67610t) was within insert limits with calibrator 73 and calibrators 80/82.At the time the complaint came in, cal lot 73 had already expired so no testing could be done internally between cal lot 73 and cal lots 80 and 82.Siemens ran the current calibrator lot 82 with reagent lot 229 to verify it meets accuracy by recovery standards.(b)(6) lot 67612t qc, in-house medical decision pool samples (mdp), and ckmb master curve material (mcm) were used.The testing included three calibration events and samples run in replicates of 3 on each calibration.All replicates of qc, mdp, mcm samples were within acceptable limits.The customers patient correlation (n=8 patients) did show a positive shift from cal73 to cals 80 and 82 however no samples changed clinical interpretation based on the ifu cutoff of 5 ng/ml.Some lot to lot variability is inherent in all immunoassays.No product performance issue was confirmed.The customer is operational.

• Brand Name: ATELLICA IM 1300 CREATINE KINASE MB (CKMB)
• Common Device Name: ATELLICA IM 1300 CKMB
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9385331
• Report Number: 1219913-2019-00253
• Device Sequence Number: 3244183
• Product Code: JHS
• UDI-Device Identifier: 00630414598574
• UDI-Public: 00630414598574
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K962126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995530
• Device Lot Number: 52304227
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1