MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CA 19-9 (CA19-9); CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING, MANAGEMENT OF PANCREATIC CANCER

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states (ous) reported observation of a discordant elevated advia centaur xp ca 19-9 result.Siemens investigation confirmed an average positive bias of 56.4% with a sample population from the asia pacific region and atellica im and advia centaur 19-9 assay kit lots ending in 535 as compared to previous lots.However, investigation did not confirm commercial quality control results outside of range.Urgent medical device correction (umdc) aimc 24-14.A.Us and urgent field safety notice (ufsn) aimc 24-14.A.Ous were distributed to customers who have received the affected product to notify them of the bias.The communication advises customers to discontinue use of the affected product.Note: this customer acknowledged the ufsn on 07-aug-2024, however a technician inadvertently used the product, which resulted in this event.Customer has since received a replacement lot and is operational.
Event or Problem Description
The customer contacted siemens to report an observation of a discordant (elevated) advia centaur xp ca 19-9, lot 535 result on a sample from a patient with no clinical history of cancer.The patient sample was initially tested with advia centaur xp ca 19-9, lot 535 and resulted above the expected normal value range (>37 u/ml).The result was reported and questioned by the physician.The patient was tested for ca19-9 at another hospital and the result was within normal range.There are no reports adverse health consequences due to this event.

• Brand Name: ADVIA CENTAUR CA 19-9 (CA19-9)
• Common Device Name: CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING, MANAGEMENT OF PANCREATIC CANCER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 20254372
• Report Number: 1219913-2024-00420
• Device Sequence Number: 20843971
• Product Code: NIG
• UDI-Device Identifier: 00630414574028
• UDI-Public: (01)00630414574028(10)55972535(17)240914
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K031393
• 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
• Report Date (Section B): 09/19/2024

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: 09/14/2024
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 55972535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/19/2024
• Date Device Manufactured: 11/14/2023
• 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: 1219913-07-18-2024
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female