MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY; ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

Catalog Number	SMN 11319151
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained erroneously depressed urinary/cerebrospinal fluid protein (ucfp) results on two (2) patient samples on an advia® 2400 clinical chemistry system.The erroneous results were reported to the physician and were not questioned.The same samples were reprocessed on the same advia® 2400 clinical chemistry system.The reprocessed results obtained were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed urinary/cerebrospinal fluid protein (ucfp) results.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed urinary/cerebrospinal fluid protein (ucfp) results obtained on two (2) patient samples on an advia® 2400 clinical chemistry system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (11-jul-2024): siemens healthcare diagnostics concluded the investigation of the event.Siemens confirmed the potential for biased quality control (qc) and patient results when using advia chemistry urinary/cerebrospinal fluid protein (ucfp) lot 140 on the advia® 2400 chemistry system.Siemens¿ internal investigation confirmed when using lot 140, qc recovered outside of the allowable control limits for urine chemistry control levels.United states (us) customers were notified through an urgent medical device correction (umdc) achc24-04.A.Us.Chc, titled "advia chemistry urinary/cerebrospinal fluid protein (ucfp) lot 140 quality control (qc) out of range and biased patient results" and outside the united states (ous) customers were notified through an urgent field safety notice (ufsn) achc24-04.A.Ous.Ch, titled ¿advia chemistry urinary/cerebrospinal fluid protein (ucfp) lot 140 quality control (qc) out of range and biased patient results¿.Customers were advised to discontinue use and discard the advia ucfp lot 140.Sections h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2024-00126 was filed on 06-jun-2024.

• Brand Name: ADVIA CHEMISTRY
• Common Device Name: ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19475867
• Report Number: 2432235-2024-00126
• Device Sequence Number: 12495787
• Product Code: CEK
• UDI-Device Identifier: 00630414279176
• UDI-Public: 00630414279176
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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: 10/31/2024
• Device Catalogue Number: SMN 11319151
• Device Lot Number: 140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-08/02/2024-002-C
• Patient Sequence Number: 1
• Patient Sex: Unknown