MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ALPHA FETOPROTEIN (AFP); AFP IMMUNOASSAY

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center to report elevated atellica im alpha fetoprotein (afp) results were obtained for samples from twenty-two patients that were considered discordant with the lower repeat resuls.Siemens has completed the investigation into the discordant elevated afp results.The initial results were obtained from reagent pack (b)(4) loaded on the atellica im s/n (b)(4).In review of the calibrations, it does appear a lower rlu (relative light unit) value was obtained on reagent pack (b)(4) as compared to other reagent packs.Quality control (qc) was also biased.Once a new reagent pack was put on board, the calibration from this initial reagent pack (b)(4) was used as part of the lot calibration and qc was out of range.The new reagent pack was successfully recalibrated.The patient samples were repeated on different atellica im analyzers.The reagent pack (b)(4).Was inspected by the customer and it was noted that the pack was not homogenous.The calibration on a reagent pack that was not homogenous may be the cause of higher afp results.The customer is aware of reagent pack inspection before placing on the instrument.The ifu states in the preparing the reagents section: "all reagents are liquid and ready to use.Before loading primary reagent packs onto the system, mix them by hand and visually inspect the bottom of the reagent pack to ensure that all particles are resuspended.For information about preparing the reagents for use, refer to the online help." the ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." no further evaluation of the device is required.

Event Description

Elevated atellica im alpha fetoprotein (afp) results were obtained for samples from twenty-two patients that were considered discordant with the lower repeat resuls.The patient samples were repeated on another atellica im after control failure.The discordant results were reported to the physician and questioned.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant, afp results.

• Brand Name: ATELLICA IM ALPHA FETOPROTEIN (AFP)
• Type of Device: AFP IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avemue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 7372808688
• MDR Report Key: 15306500
• MDR Text Key: 305521873
• Report Number: 1219913-2022-00257
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P930036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10995442
• Device Lot Number: 254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1