Model Number N LATEX FLC LAMBDA |
Device Problem
High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The customer contacted a siemens customer care center and reported that an elevated free light chains (flc), type lambda (flc lambda) result was obtained on a patient sample on a bn prospec system.The customer previously contacted siemens regarding discordant flc lambda results obtained for this patient and mdrs 9610806-2019-00006 and 9610806-2019-00007 were filed for the discordant results previously obtained on the other samples from this patient.Siemens previously determined that there was no indication of a system malfunction and that the cause of the discordant flc lambda results was sample specific.The customer did not have the sample for further investigation.On (b)(6) 2019, the customer sent another sample from the same patient for further investigation; siemens further investigated the issue and a study was performed on the affected sample.The sample was tested on a bn prospec system using the same reagent, and the flc lambda result confirmed the elevated recovery observed by the customer.Analysis of the sample portrayed that the flc lambda determinations were correctly evaluated by the bn prospec system; flc lambda concentration was present in a large protein complex in the sample.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2019-00008 was filed for the elevated flc lambda result obtained on the week of (b)(6) 2019 on another sample from the patient.Supplemental mdrs 9610806-2019-00006_s2 and 9610806-2019-00007_s2 were filed for the same issue.
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Event Description
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An elevated free light chains (flc), type lambda (flc lambda) result was obtained on a patient sample on a bn prospec system.It is unknown if the elevated result was reported to the physician(s) and it is unknown if the sample was repeated.The customer reported that the patient's immunoglobulin a (kappa) m component was increasing and that the patient's bone marrow was collected the week prior to (b)(6) 2019; the customer reported that there was presence of kappa positive plasma cells in the patient's bone marrow.There are no known reports of patient intervention or adverse health consequences due to the elevated flc lambda result.
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Manufacturer Narrative
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Siemens filed the initial mdr 9610806-2019-00009 on 12-feb-2019.Corrected information (06-feb-2019): the customer clarified that the free light chains (flc), type lambda (flc lambda) result of 13,600 mg/l was obtained on 24-jan-2019.Additional information (06-feb-2019): the customer reported that additional elevated flc lambda results were obtained on sample(s) from the patient and mdrs 9610806-2019-00011, 9610806-2019-00012, 9610806-2019-00013, and 9610806-2019-00014 were filed for the additional elevated flc lambda results.The system is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2019-00006_s3, 9610806-2019-00007_s3, and 9610806-2019-00008_s1 were also filed for the same issue.
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Event Description
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The elevated free light chains (flc), type lambda (flc lambda) result obtained on the bn prospec system was reported to the physician(s).
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Manufacturer Narrative
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Siemens filed the initial mdr 9610806-2019-00009 on 12-feb-2019 and the first supplemental mdr on 07-mar-2019.Additional information (08-mar-2019): the customer indicated that the elevated free light chains (flc), type lambda (flc lambda) result obtained on the bn prospec system was reported to the physician(s).Mdrs 9610806-2019-00011_s1, 9610806-2019-00012_s1, 9610806-2019-00013_s1 and 9610806-2019-00014_s1 were filed for the same issue.
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Manufacturer Narrative
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Siemens filed the initial mdr 9610806-2019-00009 on 12-feb-2019, first supplemental mdr on 07-mar-2019, and second supplemental mdr on 04-apr-2019.Additional information (21-jun-2019): the customer provided another sample from the patient for further investigation.It was determined that the sample was shipped under unacceptable conditions.Upon arrival, the sample was analyzed for free light chains (flc), type lambda (flc lambda) on a bn prospec system to evaluate whether the sample was acceptable for further investigation.The flc lambda concentration in the sample was 17,000 mg/l; compared to the flc concentrations in previous samples, the flc lambda concentration in this sample was higher and the sample was subjected to further testing.The investigation demonstrated that the sample did not contain elevated flc lambda concentrations and the result obtained on the bn prospec system was discordant, falsely elevated.In this unique sample, due to an unknown reason, the n latex flc lambda assay detected another molecule as flc lambda.This molecule, that was analyzed as flc lambda by the n latex flc lambda assay, was not identified during the investigation.This phenomenon is specific to this patient.Based on the additional information, the information from section d1, section d2, section d4, section g1,2 (continued), and section g5 were updated.Mdr 9610806-2019-00006_s4, mdr 9610806-2019-00007_s4, mdr 9610806-2019-00008_s2, mdr 9610806-2019-00011_s2, mdr 9610806-2019-00012_s2, mdr 9610806-2019-00013_s2, and mdr 9610806-2019-00014_s2 were filed for the same event.
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Search Alerts/Recalls
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