Model Number 10445158 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a discordant falsely depressed patient sample result on a dimension vista system.There were no known reports of adverse health consequences or potential for serious injury to the patient due to the discordant magnesium result or treatment administered.This mdr is being filed conservatively as the patient received magnesium.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the falsely depressed patient sample magnesium result on a dimension vista system.Siemens healthineers has confirmed that the dimension vista magnesium (mg) flex reagent cartridge lots 21253bb, 21263ba and 21335aa may show higher imprecision across the analytical measurement range for quality control and patient samples.Customers have reported a maximum negative difference of (b)(6) mg/dl (-0.9 mmol/l) between two replicates and maximum positive difference between two replicates to be 1.5 mg/dl (0.6 mmol/l).Urgent medical device correction vc-22-01.A.Us was issued to united states customers and urgent field safety notice (ufsn) vc 22-01.A.Ous was sent to outside the us (ous) customers advising customer to discontinue use and discard these dimension vista magnesium lots.
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Event Description
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A discordant, falsely depressed magnesium (mg) patient sample result was obtained on a dimension vista 1500 system.The result was reported to the physician.The same sample was reprocessed on an alternative dimension vista system and a higher result, considered correct, was obtained.A corrected report was issued.The patient was administered magnesium based on the discordant result.There were no known reports of adverse health consequences to the patient due to the discordant magnesium result or treatment.
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Manufacturer Narrative
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Additional information (18-feb-2022).Siemens healthcare diagnostics, inc.Filed corrections and removal report (crr) dated 08-feb-2022 with the fda per 21 cfr 806.10.Root cause investigation is in progress and corrective action updates will be provided in monthly status update reports to the fda as per 21 cfr part 806.10.Initial mdr 2517506-2022-00031 was filed 18-feb-2022.
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Search Alerts/Recalls
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