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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DCA VANTAGE ANALYZER; ASSAY, GLYCOSYLATED HEMOGLOBIN
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SIEMENS HEALTHCARE DIAGNOSTICS INC. DCA VANTAGE ANALYZER; ASSAY, GLYCOSYLATED HEMOGLOBIN Back to Search Results
Model Number 10282969
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2024
Event Type  malfunction  
Event Description
Discrepancies in point of care (poc) hemoglobin a1c results were noted when compared to laboratory values.When point of care results were in question, the providers elected to confirm testing by sending specimens to the lab, and thus the discrepancies were noted.The point of care department launched an extensive investigation into these claims with various devices and cartridge lot numbers.The poc clia (clinical laboratory improvement amendments) director reviewed the data and concluded that a positive bias was observed across multiple cartridge lot numbers.The affected lot numbers as part of the study include: 0672123, exp.12/31/2025, 0658113, exp.11/30/2025, and 0655103, exp.10/31/2025.
 
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Brand Name
DCA VANTAGE ANALYZER
Type of Device
ASSAY, GLYCOSYLATED HEMOGLOBIN
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict avenue
tarrytown NY 10591
MDR Report Key18649527
MDR Text Key334628807
Report Number18649527
Device Sequence Number1
Product Code LCP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/29/2024,01/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10282969
Device Catalogue Number5075US
Device Lot Number0672123, 0658113, 0655103
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2024
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/06/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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