MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA; DIMENSION VISTA® (PROG) PROGESTERONE FLEX® REAGENT CARTRIDGE

Model Number	10461743
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) concerning a discordant, falsely elevated progesterone (prog) result on a dimension vista 500 system.Siemens is investigating the event.
Event or Problem Description
A discordant, falsely elevated progesterone (prog) result was obtained on a patient sample on a dimension vista 500 system.The result was reported and questioned by the physician.The same sample was reprocessed on multiple later dates and similar recoveries were obtained.The same sample was processed by two alternate methodologies and lower, below assay range results were obtained.The lower results were considered correct by customer, consistent with patient history.There are no known reports of patient intervention or adverse health consequences due to the discrepant progesterone result.
Additional Manufacturer Narrative
Initial mdr 2517506-2021-00060 was filed 18-feb-2021.Additional information (12-mar-2021): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely elevated patient sample progesterone (prog) results.Progesterone results obtained for the same patient sample with alternate non-siemens methodologies were significantly lower.Hsc evaluated the information provided and the instrument data files.Quality control was within acceptance range and no issues were noted with other patient samples indicating that the instrument and assay were performing acceptably.This event is singular in nature and is limited to a specific patient sample.Hsc requested the patient sample for internal evaluation but no sample was provided.No product non-conformance with the assay or instrument was 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® (PROG) PROGESTERONE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 11345928
• Report Number: 2517506-2021-00060
• Device Sequence Number: 16435567
• Product Code: JLS
• UDI-Device Identifier: 00842768026478
• UDI-Public: 00842768026478
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• 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: 01/30/2021
• Device Model Number: 10461743
• Device Catalogue Number: K6464 SMN 10461743
• Device Lot Number: 20216BB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/18/2021
• 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