MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2); ENZYMATIC METHOD, BILIRUBIN

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	08/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed total bilirubin_2 (tbil_2) neonate patient result obtained on an atellica ch 930 instrument.Siemens healthcare diagnostics is investigating the event.
Event or Problem Description
The customer reported an erroneously depressed total bilirubin_2 (tbil_2) neonate patient sample result was obtained on an atellica ch 930 analyzer.The erroneous result was reported to the physician(s), who questioned the result as the neonate had jaundice.A second (different) sample was processed on an alternate siemens methodology (rp500e blood gas analyzer).A higher result was obtained, considered correct, and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed total bilirubin_2 (tbil_2) result.
Additional Manufacturer Narrative
Additional information (20-sep-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer.No reagent or instrument issues were identified.Quality control (qc) recovered within the customer¿s acceptable ranges.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr was filed on 13-sep-2024.

• Brand Name: ATELLICA CH TOTAL BILIRUBIN_2 (TBIL_2)
• Common Device Name: ENZYMATIC METHOD, BILIRUBIN
• 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: 20216906
• Report Number: 2432235-2024-00206
• Device Sequence Number: 7450341
• Product Code: JFM
• UDI-Device Identifier: 00630414595818
• UDI-Public: (01)00630414595818(0)140170(17)250728
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170065
• 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): 10/15/2024

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: 07/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 11097531
• Device Lot Number: 140170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/15/2024
• Date Device Manufactured: 05/16/2024
• 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: A
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Unknown