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 36380.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.
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Siemens filed the initial mdr 2432235-2023-00395 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 2432235-2022-00393_s1 and 2432235-2022-00394_s1 were also filed for the additional information.
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