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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 07/29/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report discordant (elevated) atellica im vitamin b12 (vb12) patient results compared to lower retest results obtained on a different day with a different instrument and reagent lot.The limitations section of the instructions for use states: "for diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings." siemens is investigating.

Event Description

The customer identified discordant (elevated) vitamin b12 (vb12) patient results on atellica im 1600 instrument # ih00610, reagent lot 280 compared to lower retest results obtained on a different day with a different atellica im instrument and reagent lot.The customer believes the repeat results are correct.The initial results were reported to physician(s) and were questioned.Corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the discordant vb12 results.

Manufacturer Narrative

Siemens filed mdr 1219913-2022-00274 initial report on 2022-09-02.Additional information: 2022-11-30: siemens performed an atellica im vitamin b12 (vb12) study using internal medical decision pool (mdp) controls and bio-rad lyphochek controls.The internal mdp controls and bio-rad lyphochek controls resulted within range.Bio-rad liquichek controls were also tested; lot 85290 recovered within acceptable ranges, but lot 85310 recovered high out of range with the level one (85311) control.The siemens internal study did not replicate the customer observed failures with mdps, bio-rad lyphochek or bio-rad liquichek lot 85290, but did replicate the customer observed failures with bio-rad liquichek lot 85310.Bio-rad unity data was reviewed and showed a cumulative recovery of lot 85310 was higher than the target value for all three control levels.Siemens reviewed previous internal studies for vb12 that used fresh drawn patient samples.Results indicated that the quality of the specimen could potentially impact the performance of the atellica im vb12 assay.Cellular debris could potentially be responsible for the higher than expected vb12 results.Siemens recommends following all handling instructions provided by the sample collection tube manufacturer.Additional information - 2022-12-06 siemens concluded investigation for an outside of the united states (ous) customer observation of discordant (elevated) atellica im vitamin b12 (vb12) patient results compared to lower retest results obtained on a different day with a different instrument and reagent lot.The patients were initially tested on analyzer # ih00610 and retested on alternate atellica im analyzer at the customer site.The patient samples in question all demonstrated a decrease in results when retested on a later date.Upon review of the complaint data, it was noted that the retests of the patient samples occurred 3-4 days later, and testing was performed on an alternate reagent lot.Per the storing the specimen section of the atellica im vb12 instructions for use (ifu), 10995437_en rev.02, 2019-08, patient samples must be frozen at

• Brand Name: ATELLICA IM VITAMIN B12 (VB12)
• Type of Device: VITAMIN B12 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 ; 3392064073
• MDR Report Key: 15352368
• MDR Text Key: 305687285
• Report Number: 1219913-2022-00274
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 00630414600284
• UDI-Public: 00630414600284
• 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: 12/19/2022

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 Model Number: N/A
• Device Catalogue Number: 10995715
• Device Lot Number: 280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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