MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH CREATININE_2 (CREA_2); CREATININE_2 ASSAY

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

An outside the united states customer observed falsely depressed creatinine_2 (crea_2) results on six patient samples on an atellica ch analyser, lot 221736.The erroneous results were reported to the physician(s).The results were not questioned by the physician(s).The samples were reprocessed on an original instrument.The repeat results were higher than the initial results.The repeat results were considered as correct results by the physician(s).Quality controls (qc) were in range at the time of the event.The interpretation of results section of the atellica ch crea_2 instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".Siemens healthcare diagnostics is investigating.

Event Description

The customer observed falsely depressed creatinine_2 (crea_2) results on six patient samples on an atellica ch analyser, lot 221736.The erroneous results were reported to the physician(s).The results were not questioned by the physician(s).The samples were reprocessed on an original instrument.The repeat results were higher than the initial results.The repeat results were considered as correct results by the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed crea_2 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2023-00086 on apr 13, 2023.Additional information: apr 21, 2023 and may 04, 2023: the customer observed falsely depressed creatinine_2 (crea_2) results on six patient samples on an atellica ch analyser, lot 221736.The erroneous results were reported to the physician(s).The results were not questioned by the physician(s).The samples were reprocessed on the original instrument.The repeat results were higher than the initial results.The repeat results were considered as correct results by the physician(s).The customer provided the gender of all patient samples.Sample ids gender (b)(6) male (b)(6) male (b)(6) female (b)(6) female (b)(6) male (b)(6) female siemens was unable to obtain information to determine if there is an indication of reagent delivery, or if there is evidence that a foaming issue occurred without photometer or result monitor data.No maintenance information was available for atellica cm01751.Siemens was unable to query atellica cm01751 for process errors posted on (b)(6) 2023.The initial issue was reported as discordant (low) atellica creatinine_2 (crea_2) results.Siemens cannot definitively determine the cause of this discrepant result.Contributing factors such as sample integrity, preanalytical variables cannot be ruled out.Quality control was in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.Repeat of the same sample yielded expected results.Based on the results of the investigation, return of the patient sample is not warranted.A potential product issue has not been identified.Customer instrument is fully functional.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA CH CREATININE_2 (CREA_2)
• Type of Device: CREATININE_2 ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin co. antrim, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16732806
• MDR Text Key: 313221562
• Report Number: 1219913-2023-00086
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: 00630414596457
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K161494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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: 10/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 11097596
• Device Lot Number: 221736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1