Model Number ADVIA CHEMISTRY LIPASE (LIP) |
Device Problem
Imprecision (1307)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Siemens healthcare diagnostics, inc.Has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using advia chemistry lipase reagent lot 485700.Preliminary investigation has indicated that not all cartons within this reagent lot are impacted.An urgent medical device recall (umdr) chc 20-03.A.Us was sent to us customers and an urgent field safety notice (ufsn) chc 20-03.A.Ous was sent to ous customers in december 2019.The umdr and ufsn advise customers of the investigation with the advia chemistry lipase reagent lot 485700 and provide instructions to help determine if the lipase reagent cartons in their inventory are impacted.If the cartons in the customers inventory are not impacted, the customers are instructed to proceed to using the cartons according to the instructions for use.If the cartons in the customers inventory are impacted, the customers are instructed to discard the impacted cartons and can request replacement.The next reagent lot is expected to be available by february 2020.If replacement kits are not available, customers are instructed to test patient samples using an alternate methodology.
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Event Description
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The customer contacted siemens customer care center (ccc) to report that imprecision were observed for lipase (lip) kit lot 485700 while using an advia 1800 instrument.Based on the performance of qc and the precision study, the customer is not using this reagent lot for patient testing.Samples are being sent to an alternate laboratory for testing.Customer did not provide any patient results.There are no known reports of patient intervention or adverse health consequences due to the imprecision observed with the lip assay.
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Event Description
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The laboratory continues to process lipase samples according to siemen's recommendations on working reagent boxes.
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Manufacturer Narrative
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Initial mdr 2432235-2020-00025 was filed on 10-jan-2020.Corrected information (14-jan-2020): corrected date of first event ((b)(6) 2019).Additional information (17-jan-2020): siemens was notified by the customer that the laboratory continues to process lipase samples according to siemen's recommendations on working reagent boxes.Sections b3 and b5 were updated.
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Search Alerts/Recalls
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