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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant results is unknown.Siemens healthcare diagnostics is investigating.The instructions for use states: "warning 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." mdr 1219913-2020-00071 was filed for the same event for the initial result.

Event Description

A customer obtained a discordant elevated atellica im afp result for a patient sample.Additional testing was performed with the same sample on the same instrument at a later time on the same day.One of those results was also elevated.The customer indicated that patient history gave confidence that the elevated results were discordant.The discordant elevated results were not reported to the physician.The lower repeated results were reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant afp results.

Manufacturer Narrative

Siemens filed initial mdr 1219913-2020-00072 on (b)(6) 2020.Additional information (b)(6) 2020: customer confirmed that sample plid334 is the same sample as plid3341so00 listed in the raw data attachment.Customer confirmed that a correct result of 4.2 ng/ml was reported to physician for sample pkiz760; no other results were reported to physician for this sample.Customer confirmed that sample plid334 is from a 79 year old male; no other patient information was provided.Customer confirms that becasue the reported result was aligned with expectations, this sample was not tested with other methodologies.Additional information (b)(6) 2020: a discordant high atellica immunoassay (im) alpha fetoprotein (afp) result was obtained for sample plid334 on (b)(6) 2020.The sample was repeated on the same instrument with the same reagent pack and calibration.The 3 repeat results align with the physicians expected results for the sample, while the original result and 1 repeat result were elevated (discordant).A service request was opened on (b)(6) 2020, however no service was performed because a precision study was conducted on (b)(6) 2020 with 10 replicates.The results of the precision study were within the criteria documented in the assay instructions for use.As such, the sample was not requested for analysis by siemens.The probable cause of the discordant results is incomplete wash or aspiration, or base dripping in the luminometer, which can be resolved with routine troubleshooting.Siemens investigation is complete.Based on the investigation, no product problem was identified.Mdr 1219913-2020-00071 supplemental report 1 was filed for the initial discordant result.

• Brand Name: ALPHA FETOPROTEIN (AFP)
• Type of Device: ALPHA FETOPROTEIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9732299
• MDR Text Key: 196073529
• Report Number: 1219913-2020-00072
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995441
• Device Lot Number: 45932219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR