MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM 1300 ALPHA FETOPROTEIN (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 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the elevated, non-reproducible afp result on the atellica im 1300 is unknown.Siemens has requested additional information to investigate the issue.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

Customer observed an elevated alpha fetoprotein (afp) result on the atellica im 1300 that did not match the clinical picture or repeat results.The result was reported to the physician who questioned the result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated atellica im afp result.

Manufacturer Narrative

Mdr was filed on may 29, 2019 reporting that a customer observed an elevated alpha fetoprotein (afp) result on the atellica im 1300 that did not match the clinical picture or repeat results.July 17, 2019, additional information: siemens has concluded this investigation into one high initial afp value that repeated lower.The initial and repeat for other tests were slightly different including h going from 5 to 1 and ld going from 559 to 326.This might indicate there may have been preanalytical issues with the initial sample.Based on the available information, the cause of the non-reproducible result cannot be determined.There does not appear to be a systemic issue.

• Brand Name: ATELLICA IM 1300 ALPHA FETOPROTEIN (AFP)
• Type of Device: AFP IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8649352
• MDR Text Key: 146367802
• Report Number: 1219913-2019-00098
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• PMA/PMN Number: P930036
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995441
• Device Lot Number: 10938208
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR