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

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	06/11/2024
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 urinary/cerebrospinal fluid protein (ucfp) patient result obtained on an advia chemistry xpt.Siemens is investigating the event.
Event or Problem Description
The customer reported erroneously depressed urinary/cerebrospinal fluid protein (ucfp) patient sample results were obtained on an advia chemistry xpt system.The erroneously depressed sample result was reported to the physician and was not questioned.A new sample was processed on an alternate system, an atellica ch 930 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 urinary/cerebrospinal fluid protein (ucfp) result.
Additional Manufacturer Narrative
Additional information (10-sep-2024): siemens healthineers has 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® 1800 chemistry, advia® 2400 chemistry and advia® chemistry xpt systems.Siemens¿ internal investigation confirmed when using lot 140, qc may recover outside of the allowable control limits for urine chemistry and spinal fluid control levels.Us customers were notified through urgent medical device correction (umdc letter 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 ous customers were notified through urgent field safety notice (ufsn), achc24-04.A.Ous.Chc of the potential for bias quality control (qc) and patient sample results when using the atellica chemistry ucfp lot 140.The umdc and ufsn provided instructions to customers to discontinue use and discard ucfp lot 140.Section h6 has been updated to reflect the investigation.Initial mdr 2432235-2024-00195 was filed on 28-aug-2024.

• Brand Name: ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
• Common Device Name: BIURET (COLORIMETRIC), TOTAL PROTEIN
• 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; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 20081276
• Report Number: 2432235-2024-00195
• Device Sequence Number: 15343819
• Product Code: CEK
• UDI-Device Identifier: 00630414279176
• UDI-Public: (01)00630414279176(10)140(17)241031
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 09/20/2024

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 Model Number: N/A
• Device Catalogue Number: 11319151
• Device Lot Number: 140
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/20/2024
• 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 Age: 70 YR
• Patient Sex: Male