MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM VITAMIN B12 (VB12) ASSAY; VB12 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 to report high atellica im vitamin b12 (vb12) results for samples from two patients that were considered discordant when compared to the lower repeat results on the other atellica im analyzers at the customer site.The quality control (qc) run on the atellica im s/n: (b)(4) was out of range for level 1 and the customer observed a failure of the moving average for qc.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens healthcare diagnostics is investigating.

Event Description

The customer obtained high atellica im vitamin b12 (vb12) results for samples from two patients that were considered discordant when compared to the lower repeat results on the other atellica im analyzers at the customer site.The samples were repeated due to the quality control (qc) results were out of range high for the vitamin b12 (vb12) assay on the atellica im s/n ih00575.The initial results were run on atellica im s/n ih00575 with lot 280 and were considered discordant.The repeat testing for sid (b)(6) was run on atellica im s/n (b)(4) with lot 280 and was considered correct.The repeat testing for sid (b)(6) was run on atellica im s/n (b)(4)with lot 282 and was considered correct.The initial results were reported to the physician and questioned.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant vitamin b12 (vb12) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00259 on september 01, 2022.December 05, 2022 additional information: an outside of the united states (ous) customer contacted the siemens customer care center to report high atellica im vitamin b12 (vb12) results for samples from two patients that were considered discordant when compared to the lower repeat results on the other atellica im analyzers at the customer site.Siemens has investigated.Upon review of the data, it was noted that the repeats of the patient samples occurred more than 48 hours later, and testing was performed on alternate vb12 reagent lot 282.Per atellica im vb12 information for use (ifu), 10995437_en rev.02, 2019-08, patient samples must be frozen at less than or equal to -20°c if not tested within 48 hours.The customer uses an aptio high volume sample refrigeration system for sample storage and therefore samples were not frozen and not eligible for vb12 repeat testing past 48 hours.Bio-rad quality control (qc) lot 85290 (level 1 and level 2) was sporadically out of range low according to customer range but within bio-rad package insert ranges during time of patient testing and days following.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.When samples are centrifuged prior to testing and remain upright or allowed to settle for an extended period of time, the vb12 assay can be impacted resulting in lower values.Siemens recommends following all collection tube handling instructions provided by the manufacturer.Siemens performed additional testing for vb12 lot 280 and bio-rad qc lot 85290, which confirmed that this lot of bio-rad qc is performing as expected and within published package insert ranges and close to package insert means.Qc and reagent performance during the study showed no significant degradation over a 4-day period on 3 different packs of vb12 reagent lot 280.No product performance issue was found.Siemens cannot rule out issues with customer bio-rad qc supply, reagent supply or preanalytical handling of qc or patient samples as the cause of qc out of range and the discordant patient results at customer site.Based on the investigation, no product problem was identified.In section h6, an additional type of investigation code was added and the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM VITAMIN B12 (VB12) ASSAY
• Type of Device: VB12 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avemue; 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: 15334631
• MDR Text Key: 305606573
• Report Number: 1219913-2022-00259
• 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: 12/28/2022

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: 09/01/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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