Model Number 10700444 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Mdrs 2517506-2021-00022, 2517506-2021-00023, 2517506-2021-00025, 2517506-2021-00026 and 2517506-2021-00027 were filed for the same event.The customer contacted the siemens customer care center (ccc) concerning discordant, falsely depressed enzymatic creatinine (ecrea) results on dimension vista 1500 system.Siemens is investigating the event.
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Event Description
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Discordant, falsely depressed patient sample results were obtained for enzymatic creatinine (ecrea) on a dimension vista 1500 system.The results were reported to the physician(s).The same samples were reprocessed after an adjustment to the digits of precision setting on the instrument and higher results were obtained.Corrected results were reported.There are no known reports of patient intervention or adverse health consequences due to the discordant ecrea results.
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Manufacturer Narrative
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Initial mdrs 2517506-2021-00022, 2517506-2021-00023, 2517506-2021-00024, 2517506-2021-00025, 2517506-2021-00026 and 2517506-2021-00027 were filed for the same event on 21-jan-2021.Additional information (04-feb-2021): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely depressed enzymatic creatinine (ecrea) results on a dimension vista 1500 system.Hsc evaluated the information provided and the instrument data files.A siemens customer service engineer (cse) determined that the customer had processed patient samples after changing the digits of precision setting for the ecrea assay method configuration.The incorrect setting caused the ecrea sample results to be either rounded up or down to the nearest 10 or 100.The cse evaluated the system and returned the digits of precision to the correct setting of 3 which restored the system to standard operation.Quality control was within the expected range after restoring the digit of precision setting.No issues were noted with other patient samples indicating that the instrument and assay were performing acceptably.The cause of the event is use error.A potential product issue was not identified.The device is performing within specifications.No further evaluation is required.Section g1 has been updated to reflect the hsc investigation.Section h6 has been updated to reflect the hsc investigation.Mdr supplements 2517506-2021-00022 supplement 1, 2517506-2021-00023 supplement 1, 2517506-2021-00025 supplement 1, 2517506-2021-00026 supplement 1 and 2517506-2021-00027 supplement 1 were filed for the same event.
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Search Alerts/Recalls
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