Mdr 1219913-2020-00063 was filed on (b)(6) 2020 for discordant advia centaur xpt folate (fol) results were obtained on patient samples.(b)(6) 2020 - correction b3: date of event was on (b)(6) 2020 until around 01.00 am (b)(6) 2020.B4: date notified was (b)(6) 2020.(b)(6) 2020 - additional information: the advia centaur xpt folate reagent readypack, lot 288, pack id (b)(4) had an acceptable valid calibration on (b)(6) 2020.The customer has not observed other reagent readypacks with clumped non-suspended paramagnetic particles since (b)(6) 2020.(b)(6) 2020 - additional information: date of testing: (b)(6) 2020.Instrument sn: (b)(6) & (b)(6).Sid: (b)(6).Initial result: 5.8 ug/l (ng/ml).Repeat result: 4.1 ug/l (ng/ml).Siemens healthcare diagnostics is investigating.
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Mdr 1219913-2020-00063 was filed (b)(6) 2020, mdr 1219913-2020-00063 supplemental report 1 was filed on (b)(6) 2020 and mdr 1219913-2020-00063 supplemental report 2 was filed on (b)(6) 2020.(b)(6) 2020 - additional information: an analysis of the frequency of reports of aggregated paramagnetic particles (pmp) for advia centaur folate reagent lot 288 was performed.This is the only complaint received for reagent lot 288 yielding a frequency of 2.44% for great britain and 0.02%, globally.Siemens has investigated the customer's issue of advia centaur xpt folate discordant patient results observed with reagent lot 288 and evidence of clumping in one reagent readypack.The clumping observed is typical of a reagent readypack that has been shipped or stored inverted for an extended amount of time.There have been no other observations of clumping with reagent lot 288 at this site.Since there have been no additional observations of clumping reagent at this site, this indicates that the potential cause of the clumping solid phase is isolated to shipping or storage that affected only one specific reagent readypack.Siemens previously conducted an investigation regarding the appearance of aggregated paramagnetic particles pellets in solid phase reagents for the advia centaur, advia centaur xp, and advia centaur cp systems.This investigation concluded that during storage, the paramagnetic particles in the solid phase reagent well settle and form a pellet at the bottom of the primary reagent packs.To ensure optimum assay performance on the advia centaur, advia centaur xp, and advia centaur cp systems, it is critical that reagents are handled correctly during shipment and storage, and that operators mix the reagents correctly before use.The customer is currently operational.The instruction for use (ifu) under the preparing reagents states the following: "mix all primary reagent packs by hand before loading them onto the system.Visually inspect the bottom of the reagent pack to ensure that all particles are dispersed and resuspended.For detailed information about preparing the reagents for use, refer to the system operating instructions." the assay is performing within specification.No further evaluation of the device is required.Section h6 device, method, result and conclusion codes were updated to reflect the additional information.
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Mdr 1219913-2020-00063 was filed 17-feb- 2020 and mdr 1219913-2020-00063 supplemental report 1 was filed on 28-feb-2020.10-mar-2020 - additional information: customer assay kits are initially moved into inventory stores and then into the laboratory for use.As outlined in the instruction for use (ifu), reagents are mixed end to end until all the particles are dispersed and resuspended.There are no reports of the reagent kits arriving to the laboratory warm, inverted or being treated differently during shipping compared to other assay reagent kits that were received.The assay reagent kits are stored in a temperature monitored refrigerator in the laboratory.Siemens healthcare diagnostics is investigating.
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