MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC

Model Number ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The customer reported an increased incidence of quality controls (qc) for hemoglobin recovering out of range for normal qc.Siemens is investigating the issue.Mdrs 2432235-2022-00394 and 2432235-2022-00395 were filed for lots: 18367 and 36380 of the advia 120/2120/2120i cn-free cbc timepac reagent, respectively.

Event Description

The customer observed tiny black particles in the hemoglobin (hgb) reagent of the advia 120/2120/2120i cyanide free complete blood count timepac (advia 120/2120/2120i cn-free cbc timepac), lot: 65597.None of the other reagents in the advia 120/2120/2120i cn-free cbc timepac have the particles.The customer indicated that incorrect hgb results may have been obtained due to this issue, but no patient data was provided.There are no known reports of patient intervention or adverse health consequences due to this event.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2023-00393 on 20-dec-2022.Additional information (08-jun-2023): the initial report was conservatively filed due to the customer's allegation of potential erroneous hemoglobin results due to black particles in the hemoglobin reagent.However, at the time of filing, the customer did not provide patient results; at that time, the customer provided examples of out-of-range quality controls.Siemens further investigated the issue and determined that the particles have a pore size of less than 105 microns and does not impact patient results nor quality controls.Additionally, these particles would not block any tubes or apertures in the system and would flow through the system and into the waste chamber.Particles could potentially accumulate over time at junction points in the fluidics circuit.In the event that particles accumulate and results are produced, the system would flag results with hgb irregular flow rate (hgbifr, hr), making this apparent to the operator.Supplemental mdrs 2432235-2022-00394_s1 and 2432235-2022-00395_s1 were also filed for the additional information.

• Brand Name: ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC
• Type of Device: ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): THERMO FISHER SCIENTIFIC; registration # 1181121; 8365 valley pike; middletown VA 22645
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 16018710
• MDR Text Key: 308355575
• Report Number: 2432235-2022-00393
• Device Sequence Number: 1
• Product Code: GKL
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K971998
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC
• Device Catalogue Number: 10341169
• Device Lot Number: 65597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1