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

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	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding falsely depressed urinary/cerebrospinal fluid protein (ucfp) patient sample results obtained on an atellica ® ch 930 analyzer.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Siemens reviewed the information provided by the customer.No process errors were identified from the analyzer and no hardware intervention was performed on the analyzer.The device is performing within specifications.No further evaluation is required.The cause of the event is unknown.
Event or Problem Description
Six (6) falsely depressed urinary/cerebrospinal fluid protein (ucfp) patient sample results were obtained on an atellica ® ch 930 analyzer.The falsely depressed patient results were not reported to the physician.The same samples were reprocessed on an alternate atellica ® ch 930 analyzer.The higher 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 falsely depressed urinary/cerebrospinal fluid protein (ucfp) results.
Additional Manufacturer Narrative
Additional information (11-july-2024): siemens healthineers has confirmed the potential for biased quality control (qc) and patient results when using atellica ch urinary/cerebrospinal fluid protein (ucfp) lot 130414 on the atellica® ch and atellica® ci analyzers.Siemens¿ internal investigation confirmed when using lot 130414, 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), titled "atellica ch urinary/cerebrospinal fluid protein (ucfp) lot 130414 quality control (qc) out of range and biased patient results" and ous customers were identified through (urgent field safety notice (ufsn), achc24-04.A.Ous) of the potential for bias quality control (qc) and patient sample results when using the atellica ch ucfp lot 130414.The umdc and ufsn provided instructions to customers to discontinue use and discard ucfp lot 130414.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2024-00046 was filed on 08-march-2024.

• Brand Name: ATELLICA CH
• Common Device Name: 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; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 18864569
• Report Number: 2432235-2024-00046
• Device Sequence Number: 3314768
• Product Code: CEK
• UDI-Device Identifier: 00630414279206
• UDI-Public: 00630414279206
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: 10/15/2024
• Device Model Number: N/A
• Device Catalogue Number: 11097543
• Device Lot Number: 130414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• 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