MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH 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	06/06/2024
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) results obtained on two (2) patient samples on an atellica ch 930 instrument.Siemens healthcare diagnostics is investigating the event.
Event or Problem Description
The customer reported falsely depressed urinary/cerebrospinal fluid protein (ucfp) results were obtained on two (2) patient samples on an atellica ch 930 instrument s/n (b)(6).The erroneous results were reported to the physician and were not questioned.The same samples were reprocessed on the initial atellica ch 930 instrument with an alternate reagent lot.The reprocessed samples obtained higher ucfp results that were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneous depressed urinary/cerebrospinal fluid protein (ucfp) result.
Additional Manufacturer Narrative
Additional information (24-jun-2024): the instrument was not serviced by a third party.Section d8 was updated with the information.Siemens healthcare diagnostics continues to investigate the event.Initial mdr was filed on 17-jun-2024.
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.In section h6, the type of investigation, investigation finding and investigation conclusion codes were updated.Initial mdr 2432235-2024-00135 was filed on 17-jun-2024.Mdr 2432235-2024-00135 supplemental report 1 was filed on 22-jul-2024.

• Brand Name: ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
• Common Device Name: BIURET (COLORIMETRIC), TOTAL PROTEIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 19548469
• Report Number: 2432235-2024-00135
• Device Sequence Number: 4735025
• 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,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: 06/11/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 07/11/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/22/2024; 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