MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA125 II; CA125 IMMUNOASSAY

Model Number N/A

Device Problems Low Test Results (2458); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant results is unknown.Siemens healthcare diagnostics is investigating.The interpretation of results section of the instructions for uses states, "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the limitations section of the instructions for use states, "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis." mdr 1219913-2020-00067 was filed for the same event for the initial result.

Event Description

A customer obtained a discordant low advia centaur xp ca 125 ii result.The initial result was not reported to the physician because a previous result for the same patient was higher.The same sample was retested neat and diluted.The neat result obtained was similar to the initial low result, but the dilution testing results were higher.The same sample was also tested on an alternate method and a high result was obtained.It is unknown if retest results were reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ca 125 ii results.

Manufacturer Narrative

Siemens filed initial mdr 1219913-2020-00068 on february 20, 2020.Additional information 02/25/2020: as the result of an automatic dilution, a concentration of >12,000 u/ml for ca125 was reported to the physician.The physician did not question the result.There was a delay of 5 days in reporting the result to the physician.The physician did not complain about the delay.The alternate method result was 21495 u/ml.The patient is hospitalized in a hospice facility.Since the customer is not the hospital, it does not have patient clinical diagnosis, medication list or information regarding whether there was an impact on medical procedures.It is unknown whether a medical procedure or treatment, that may later be determined to have been unnecessary, was performed, but it is not alleged that harm to the user or patient was caused by the advia centaur systems ca 125 ii result.Siemens continues to investigate.Mdr 1219913-2020-00067 supplemental 1 report was filed for the same event.

Manufacturer Narrative

Siemens healthcare diagnostics filed initial mdr 1219913-2020-00068 on february 20, 2020, mdr 1219913-2020-00068 supplemental report 1 on march 11, 2020 and mdr 1219913-2020-00068 supplemental report 2 on july 2, 2020.Additional information 07/20/2020: advia centaur xp ca 125ii lot 015187 discordant results were observed with one patient sample.The requested information was not provided for siemens to completely review and understand the issue.Siemens reviewed the dilution data provided.Relative light units (rlus) were not provided and without this information it is hard to determine the exact issue.Based on the dilution results, the issue appears to be some type of interferant.The neat results are reproducible.The dilution results are reproducible.Investigation is complete.No product problem identified.Customer is operational.No further action is required.The device, method, result and conclusion codes have been updated to reflect the investigation results.Reference section h6 of this report for the updated codes.Mdr 1219913-2020-00067 supplemental 3 report was filed for the same event.

Manufacturer Narrative

Siemens filed initial mdr 1219913-2020-00068, on (b)(6) 2020, and mdr 1219913-2020-00068, supplemental report 1 was filed on (b)(6) 2020.Correction from (b)(6) 2020: the customer information listed in section e1 in the initial mdr 1219913-2020-00068 report is actually the product distributor in the country of complaint (b)(4).The actual customer information is as follows: dr.(b)(6).(b)(6).(central lab) (b)(6).Email: (b)(6).Phone: (b)(6).Additional information from (b)(6) 2020: siemens' preliminary assessment is as follows: rlus (relative light units) were not provided in the complaint and without this information it is hard to determine the exact issue.Based on the results it appears to be some type of interferant.The neat results are reproducible.The dilution results are reproducible.Siemens' investigation continues.Mdr 1219913-2020-00067, supplemental report 2 was filed for the same event for the repeat result.

• Brand Name: ADVIA CENTAUR XP CA125 II
• Type of Device: CA125 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9732660
• MDR Text Key: 196073796
• Report Number: 1219913-2020-00068
• Device Sequence Number: 1
• Product Code: LTK
• UDI-Device Identifier: 00630414461298
• UDI-Public: 00630414461298
• Combination Product (y/n): N
• PMA/PMN Number: K020828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2020
• Device Model Number: N/A
• Device Catalogue Number: 10310443
• Device Lot Number: 015187
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1