MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA; DIMENSION VISTA® (ACTM) ACETAMINOPHEN FLEX® REAGENT CARTRIDGE

Model Number	10445110
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) regarding a discordant, falsely depressed acetaminophen (actm) patient result obtained on a dimension vista 1500 system.Siemens is investigating the event.
Event or Problem Description
A discordant falsely depressed acetaminophen (actm) patient result was obtained on a dimension vista® 1500 intelligent lab system.The discordant result was reported to the physician.The sample was reprocessed with dilution on the original system.A higher result was obtained.The higher result was reported on a corrected report.A new patient sample was drawn and processed on an alternate instrument dimension vista system.A discordant falsely depressed actm result was obtained on that system and the result was not reported.The sample was reprocessed with dilution and a higher result, considered correct, was obtained and reported.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed actm results.
Additional Manufacturer Narrative
Initial mdr 2517506-2021-00063 was filed 24-feb-2021.Additional information (12-mar-2021): siemens headquarters support center (hsc) concluded their investigation of the acetaminophen (actm) patient sample results.Original processing of the patient sample produced a result below the analytical measurement range.Repeating of the original sample when auto-diluted created a reportable acetaminophen result.Hsc cannot definitively determine the cause of this discrepant result.Contributing factors such as sample specific interferent and matrix incompatibility concerns due to non-standard on-site auto-dilution actions.The patient was reported as being medicated with acetaminophen and other compounds.The customer did not report the time of ingestion of acetaminophen or other pharmacological factors which may impact acetaminophen reporting.The patient results reported no concentration of acetaminophen from either sample but hsc is unable to rule out an interferent with the available information.As per the dimension vista acetaminophen (actm) instructions for use, samples with a result less than the analytical measurement range should be reported as "less than <0.013 mmol/l".Recommended laboratory practice to confirm a below assay range result for actm would be to dilute the patient sample with a sample of a known actm concentration (example being quality control material).Product literature supports that dilution protocols for acetaminophen dilution.Hsc notes that actm quality control was within laboratory acceptance range and no issues were noted with other patient samples indicating that the instrument and assay were performing acceptably.A potential product problem has not been identified.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA® (ACTM) ACETAMINOPHEN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 11375233
• Report Number: 2517506-2021-00063
• Device Sequence Number: 11050597
• Product Code: LDP
• UDI-Device Identifier: 00842768015014
• UDI-Public: 00842768015014
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K061655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2021
• Device Model Number: 10445110
• Device Catalogue Number: K5088 SMN 10445110
• Device Lot Number: 20177AC
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR