MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH ENZYMATIC CREATININE_3 (ECRE3); ENZYMATIC METHOD, CREATININE

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report that due to out-of-range quality control in the evening (closing), patient samples were repeated for atellica ch enzymatic creatinine_3 (ecre3).Siemens healthcare diagnostics is investigating this event.
Event or Problem Description
The customer reported that due to out-of-range quality control in the evening (closing), four hundred patient samples had to be repeated for the atellica ch enzymatic creatinine_3 (ecre3) assay.The initial testing was processed on the atellica ch 930 analyzer s/n (b)(6) and the repeat testing was processed on the same atellica ch 930 analyzer after a new calibration and quality control in range.The initial results were reported to the physician(s), who did not question the results.A corrected report was issued.Patient data was not provided for evaluation, and it is unknown if results were discordant.One example was provided showing an initial result was lower than the repeat.There are no known reports of patient intervention or adverse health consequences due to the discordant enzymatic creatinine_3 (ecre3) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2023-00283 on december 26, 2023.An outside united states (ous) customer contacted a siemens customer care center to report that due to out-of-range quality control in the evening (closing), patient samples were repeated for atellica ch enzymatic creatinine_3 (ecre3).January 03, 2024 additional information: the patient sample data was requested and was not provided by the customer.Siemens reviewed instrument data and noted the following: ¿ reagent lot 130153 was in use on atellica ch 930 analyzer (b)(6) on (b)(6) 2023 and (b)(6) 2023.¿ level sense queries show no abnormalities for the ecre3 method, and the reagent tracked down as expected.¿ calibration data shows both calibrations were valid and acceptable for use.No outliers present within the calibrations.¿ quality control data from (b)(6) 2023 showed two replicates of inteliq assay multiqual ((b)(4)) as being outside of the customers ranges.All other qc performed for serum and urine sample types were within the customers acceptable ranges.¿ the published insert sheets from biorad were reviewed and both replicates of qc (b)(4) were within the manufacturer's acceptable ranges.In addition, siemens pulled field peer unity data and the customer is recovering qc comparable to others running the same method on the atellica ch analyzers.There is no evidence of a reagent or method issue.Further investigation is not possible without the sample ids and the alleged discordant results.The instrument is operational.In section h6, the investigation finding and investigation conclusion codes were updated.

• Brand Name: ATELLICA CH ENZYMATIC CREATININE_3 (ECRE3)
• Common Device Name: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 18393574
• Report Number: 2517506-2023-00283
• Device Sequence Number: 8549306
• Product Code: JFY
• UDI-Device Identifier: 00630414610948
• UDI-Public: 00630414610948
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K212223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 07/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 11537216
• Device Lot Number: 130153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown