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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has completed the investigation into one initially discordant high atellica im alpha-fetoprotein (afp) result with reagent lot 221 that repeated as negative with reagent lot 224.There is no sample left for siemens to perform additional testing.Two months of quality control data was reviewed, and no fliers were observed.Calibrations were acceptable and no errors were found in the instrument error log.Siemens in house data was reviewed for both reagent lots 221 and 224 and no fliers were observed.Siemens cannot rule out preanalytical handling of the sample.Customer is running without any further issue.No product nonconformance was identified.No further investigation required.(b)(4).

Event Description

A customer obtained an elevated atellica im alpha-fetoprotein (afp) initial result for one patient.The result was reported to the physician.The complaint record indicated that the physician did not question the result.The customer stated that there was no sample integrity issue observed when the sample was visually checked.There was no bias, trend or shift observed in quality control data.The patient went to a different laboratory (non-customer site) for testing with an alternate method.The alternate method result (5 ug/l) was considered to be in normal range.The patient's sample from the non-customer laboratory was sent to the customer site and tested with atellica im afp, using a different reagent lot than was used to test the initial sample.The results were lower than the initial result.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant afp result.

• 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; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 5084635000
• MDR Report Key: 10518781
• MDR Text Key: 228172616
• Report Number: 1219913-2020-00237
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P930036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995441
• Device Lot Number: 221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1