MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2); 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	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding an erroneous depressed enzymatic creatinine_2 (ecre_2) patient sample result obtained on an atellica ch 930 instrument.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data and sample id 12087346 was identified with a result of <9 umol/l and flagged with a "foam error".The sample was visually inspected and bubbles were present.The probable cause for the discordant result is sample quality.There is no evidence of a potential product issue.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported an erroneous depressed enzymatic creatinine_2 (ecre_2) patient sample result obtained on an atellica ch 930 instrument.The erroneous result was not reported to the physician.The sample was reprocessed on the initial atellica ch 930 instrument.The reprocessed higher result obtained was reported, as the correct result, to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneous depressed enzymatic creatinine_2 (ecre_2) result.

• Brand Name: ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2)
• 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; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 20129690
• Report Number: 2432235-2024-00200
• Device Sequence Number: 3187382
• Product Code: JFY
• UDI-Device Identifier: 00630414595795
• UDI-Public: (01)00630414595795(10)140113(17)250318
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K070727
• 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
• Report Date (Section B): 09/03/2024

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: 03/18/2025
• Device Model Number: N/A
• Device Catalogue Number: 11097533
• Device Lot Number: 140113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/03/2024
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Female