MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® TBI TOTAL BILIRUBIN FLEX® REAGENT CARTRIDGE

Model Number	10444957
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding discordant falsely depressed total bilirubin (tbi) patient sample results obtained on a dimension exl 200 system.Siemens is investigating the event.
Event or Problem Description
Discordant falsely depressed total bilirubin (tbi) patient sample results were obtained on a dimension exl 200 system.The results were reported to the physician(s) who questioned the results.The same samples were reprocessed on the same instrument and higher results were obtained.Corrected reports issued for some samples.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed tbi results.
Additional Manufacturer Narrative
Additional information (02-jun-2022): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the discordant falsely depressed total bilirubin (tbi) patient sample results.Hsc evaluated the information provided by the customer and the instrument data logs.A preventive maintenance service visit was performed.No additional discordant results were observed after loading a new tbi flex reagent cartridge.Repeat of the same samples yielded expected results.There is no indication of a potential product issue with the tbi assay.The cause of the event is unknown.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 2517506-2022-00139 was filed 25-may-2022.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® TBI TOTAL BILIRUBIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 14500038
• Report Number: 2517506-2022-00139
• Device Sequence Number: 17582080
• Product Code: CIG
• UDI-Device Identifier: 00842768020544
• UDI-Public: 00842768020544
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K060628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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: 03/07/2023
• Device Model Number: 10444957
• Device Catalogue Number: DF167 SMN 10444957
• Device Lot Number: EA3066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown