MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM VITAMIN B12 (VB12); RADIOASSAY, VITAMIN B12

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 06/11/2023

Event Type  malfunction  

Event Description

A falsely elevated vitamin b12 (vb12) result was obtained on a patient sample on an atellica im 1600 instrument.The erroneous result was not reported to the physician(s).The sample was repeated on two alternate atellica im instruments.The repeat results were lower than the erroneous result.The repeat results were reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated vitamin b12 (vb12) result.

Manufacturer Narrative

An outside united states (ous) customer contacted a siemens customer care center to report a falsely elevated vitamin b12 (vb12) result that was obtained on a patient sample on an atellica im 1600 instrument.The erroneous result was not reported to the physician(s).The sample was repeated on two alternate atellica im instruments.The repeat results were lower than the erroneous result.The repeat results were reported, as the correct result, to the physician(s).Calibration was valid on the day of the event.Quality control (qc) levels two and three recovered within ranges, and qc level one failed on the day of the event.The interpretation of results section of the atellica im vitamin b12 (vb12) instructions for use (ifu) states "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2023-00151 on 02-august-2023.Additional information 23-august-2023: siemens has investigated the customer report for discordant patient results for one patient sample with vitamin b12 (vb12) lot 286 on atellica im 1600 instrument (ih00340).Patient vb12 results were initially tested on ih00340 and then retested on alternate atellica im modules.The patient sample in question demonstrated a decrease in results when retested at a later time same day.No additional logs or quality control (qc) data were able to be reviewed due to the late date of escalation and logs being purged from instrument.No other patient samples were affected at this time of this isolated divergent result.Siemens cannot rule out preanalytical handling of the patient sample as the cause of the discordant patient result at customer site.The quality of the specimen could potentially impact the performance of the atellica im vb12 assays.Cellular debris could potentially be responsible for the higher-than-expected vb12 results.When samples are centrifuged prior to testing and remain upright or allowed to settle for an extended period, the vb12 assay can be impacted resulting in lower values.Siemens recommends following all collection tube handling instructions provided by the manufacturer.Siemens was unable to confirm if the customer is operational or if additional assistance was needed as no response was received upon multiple attempts to request for update.The atellica im vitamin b12 (vb12) lot 286 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: ATELLICA IM VITAMIN B12 (VB12)
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 17443803
• MDR Text Key: 320235342
• Report Number: 1219913-2023-00151
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K993571
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995715
• Device Lot Number: 286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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
• Patient Age: 2 YR
• Patient Sex: Female