MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP AFP; AFP IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant afp result is unknown.Siemens healthcare diagnostics is investigating.The warning section of the instructions for use states: "warning the concentration of afp in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the afp assay used.Values obtained with different afp assay methods cannot be used interchangeably.Before changing assay methods, the laboratory must do the following: for prenatal testing, the laboratory must establish a range of normal values for the new assay based on normal serum and amniotic fluid from pregnant women with a confirmed gestational age.For cancer management, the laboratory must perform additional testing to confirm baseline values for patients being serially monitored.United states federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.Use afp results only as part of the overall clinical evaluation of a patient.Do not use afp results as the only criterion for diagnosis." the interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

The customer observed an elevated advia centaur cp alpha-fetoprotein (afp) result compared to repeat testing of the sample.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur cp afp result.

Manufacturer Narrative

Mdr 1219913-2019-00254 was filed on december 5, 2019 reporting the customer observation of an elevated advia centaur cp afp result compared to repeat testing of the sample.The customer stated that the initial result was not reported to the physician.The test was part of a physical examination.The sample was drawn in a coagulation-promoting vacuum tube.Siemens reviewed the error log and checked for air bubbles in the tubing.The wash station pump was replaced.An aspirate bubble detector calibration was performed.Qc results were within range.The system is performing acceptable.With the information provided to date, siemens cannot determine if the sample was drawn correctly allowing a full clot to form.A single high result is likely not caused by the instrument and is most likely attributed to preanalytical handling.Siemens reviewed internal release data for reagent lots ending in 211 and no issues were identified.No product nonconformance was identified and the customer has not reported any further discrepancies.No further investigation is required.

• Brand Name: ADVIA CENTAUR CP AFP
• Type of Device: AFP IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9416042
• MDR Text Key: 195077465
• Report Number: 1219913-2019-00254
• Device Sequence Number: 1
• Product Code: LOJ
• UDI-Device Identifier: 00630414177328
• UDI-Public: 00630414177328
• Combination Product (y/n): N
• PMA/PMN Number: K020806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2020
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 041211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR