SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE® 2000 HUMAN CHORIONIC GONADOTROPIN (HCG)
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Model Number N/A |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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An outside of the united states (ous) customer obtained falsely elevated human chorionic gonadotropin (hcg) results on multiple patient samples using lot 466 on the immulite 2000 xpi instrument.Preventative maintenance was performed on the instrument.Additionally, the probe and dual resolution dilutors (drd) alignments and connections on the instrument were checked.A water test was also processed and a precision test was performed using patient samples.The probes were also cleaned and a system check was performed.Furthermore, the customer's handling of kits, adjustments, quality control material, and samples were also reviewed and the instrument was decontaminated.The instrument was performing within specifications.Siemens is investigating the issue.Mdrs 1219913-2022-00061, 1219913-2022-00062, 1219913-2022-00063, 1219913-2022-00065, 1219913-2022-00066, 1219913-2022-00067 and 1219913-2022-00068 were filed for the same event.
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Event Description
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Two falsely elevated human chorionic gonadotropin (hcg) results were obtained on one patient sample on immulite 2000 xpi instrument.The falsely elevated results were not reported to the physician(s).The sample was repeated on an alternate (non-siemens) instrument.The result obtained on the alternate instrument recovered lower than the initial and first repeat results.The repeat result from the alternate (non siemens) instrument was reported, as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated hcg result.
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Manufacturer Narrative
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Siemens filed the initial mdr 1219913-2022-00064 on 21-feb-2022.Additional information (22-feb-2022): siemens healthcare diagnostics further investigated the issue and confirmed the potential for falsely elevated human chorionic gonadotropin (hcg) results due to sample carryover.This can be observed when a sample is assayed for hcg immediately after an undiluted sample with a hcg value of >5000 miu/ml.This issue impacts serum and urine patient samples, as well as quality control samples and adjustors.The effect of carryover varies based on the concentration of the high hcg sample.Starting (b)(6) 2022, an urgent medical device correction (umdc, letter imc22-04.A.Us) was sent to us customers, and an urgent field safety notice (ufsn, letter imc22-04.A.Ous) was sent to outside the us (ous).The umdc and ufsn explain the potential for carryover from high hcg samples into the next sample assayed for hcg on the immulite 2000/immulite 2000 xpi, and provides instructions to the customers.The component code, type of investigation, investigation findings and investigation conclusion codes in section h6 and section h9 were updated based on the additional information.Mdrs 1219913-2022-00061_s1, 1219913-2022-00062_s1, 1219913-2022-00063_s1, 1219913-2022-00065_s1, 1219913-2022-00066_s1, 1219913-2022-00067_s1 and 1219913-2022-00068_s1 were filed for the same event.
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