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The cause of the dimension xpand plus ft4 result regarded by the physician as possibly discordant low is unknown.The patient sample was tested (b)(6) 2016.It is unknown if the normal value for ft4 obtained on the dimension xpand plus instrument represents an erroneous result as no repeat testing for this sample was performed.According to the laboratory personnel, the physician later stated that the patient suffered a serious injury since the free thyroxine (ft4) result on the dimension xpand plus instrument should have been higher rather than normal.He stated that if the result had been high, he would have adjusted the patient's medication and without the adjustment, the physician states the patient went into atrial fibrillation (afib).The patient was being treated with 50 mg of propylthiouracil and no changes were made to the patient's medication based upon the dimension xpand result.The patient was admitted to another hospital on (b)(6) 2016 and diagnosed with afib.On such later date, an ft4 test was performed on a different manufacturer's medical device instrumentation and that produced a result above the hospital's ft4 reference range.No tsh testing was performed at the other hospital.Treatment performed in the hospital was not known, however, the patient was discharged from the hospital on (b)(6) 2016.Statements attributed to the physician are derived from information submitted to the complaint handling system and haven't been verified.No sample has been provided for siemens healthcare diagnostics evaluation.Analysis of the information provided indicates that the patient appears to be diagnosed with hyperthyroidism given treatment with propylthiouracil, an antithyroid agent used to treat this disease.Thyroid function tests are recommended every 4 to 6 weeks for monitoring patients dosed with propylthiouracil until euthyroid, including tsh and serum free t3 and t4.It is unknown if the normal value for free t4 obtained on (b)(6) 2016 represents an erroneous result because no repeat testing for this patient sample was performed.Note that the repeat free t4 was performed on an alternate platform using a sample collected on (b)(6) 2016 more than six (6) weeks after the dimension result and therefore a direct comparison between the initial and repeat values cannot be made.Current clinical guidelines stress assessment of both free t3 and free t4 levels when monitoring patients taking propylthiouracil as free t3 measurements may remain high in some types of hyperthyroidism despite normalization of free t4.In this case, values for free t3 have not been provided from the subsequent date and it is unknown if it was performed.It is not possible to assess potential clinical impact in this instance without an understanding of the complete clinical picture (e.G.Results for all thyroid analytes) as it is unknown whether the alleged discordant free t4 result alone precluded a change in treatment that would have been otherwise suggested in accordance with clinical guidelines.In addition, tsh results below the reference interval in a patient being treated for hyperthyroidism should be questioned, resulting in additional thyroid function testing such as total and/or free t3, before decisions on whether or not to adjust dosing are made.An elderly patient with a history of hyperthyroidism, cva, and ckd would be typically closely monitored, mitigating the potential for injury in this type of scenario.
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A possible discordant low free thyroxine (ft4) result was obtained on (b)(6) 2016 on a patient sample on the dimension xpand plus instrument.A thyroid stimulating hormone (tsh) result was also obtained below the reference range on the same sample.The possible discordant ft4 result was not questioned by the physician initially.On (b)(6) 2016, another sample was obtained from the patient.This later sample was run on a non-siemens methodology, producing a higher result.The later result was reported to the physician who then questioned the initial ft4 result.The physician stated that if the ft4 result had been high, he would have adjusted the patient's medication.The physician stated that adjustment of the patient's medication was not made on the basis of the first, normal ft4 result obtained on the dimension xpand plus instrument.The physician stated the patient experienced atrial fibrillation (afib) due to not making an adjustment to the medication.There is no further indication of adverse health consequences due to the possible discordant low ft4 result.Statements attributed to the physician are derived from information submitted to the complaint handling system and haven't been verified.
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