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

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 10/22/2021

Event Type  malfunction  

Event Description

The customer reported discordant depressed alpha fetoprotein (afp) results for a female patient's sample with the atellica im 1600 instrument when compared to the immulite analyzer at a different site.The patient was tested on three other days neat and diluted for afp and the diluted results were higher.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, atellica im afp results.

Manufacturer Narrative

An outside the united states (ous) customer reported depressed alpha fetoprotein (afp) results for a female patient's sample with the atellica im 1600 instrument when compared to an alternate method.Siemens is investigating.Mdr 1219913-2021-00486 was filed for the discordant observation of (b)(6) 2021 (atellica im analyzer), mdr 1219913-2021-00487 was filed for the discordant observation of (b)(6) 2021 (immulite analyzer) and mdr 1219913-2021-00491 was filed for the discordant observation of (b)(6) 2021 (atellica im analyzer).

Manufacturer Narrative

The initial mdr 1219913-2021-00488 was filed on november 19, 2021.Additional information: december 14, 2021: an outside the united states (ous) customer reported high results for afp, needed clarification as to why on one method the neat result reported greater linearity and one method reported on curve.In further review of this case, it is likely a hook sample that hooked back into the curve due to the high amount of afp antigen present.As per the interpretation of results section in the atellica im afp instructions for use 10995310_en rev.03, 2020-02, "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." furthermore, as per the interpretation of results section instructions for use: "high afp concentrations can cause a paradoxical decrease in the rlus (high dose hook effect).In this assay, patient samples with afp concentrations above the measuring interval and as high as 1,000,000 ng/ml (830,000 iu/ml) will report >1,000.0 ng/ml (830.00 iu/ml).Results were established using the atellica im analyzer".There is insufficient sample to be sent in.The immulite and atellica im afp assays have no claim for correlation however, they do both have the same intended use.In house data was reviewed for atellica afp kit lot 238 and all release criteria was met.There has been no further request for technical assistance.No product nonconformance identified.In section h6, investigation findings, and investigation conclusion codes were updated based on the investigation results.Mdr 1219913-2021-00486 supplemental 1, mdr 1219913-2021- 00487 supplemental 1 and mdr 1219913-2021-00491 supplemental 1 were filed for the same patient.

• Brand Name: ATELLICA IM ALPHA-FETOPROTEIN (AFP)
• Type of Device: ALPHA-FETOPROTEIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; 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: 12844268
• MDR Text Key: 288197871
• Report Number: 1219913-2021-00488
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995441
• Device Lot Number: 238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• 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
• Patient Age: 11 YR
• Patient Sex: Female