MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA; DIMENSION VISTA® AMM AMMONIA FLEX® REAGENT CARTRIDGE

Model Number	10711992
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a discordant, falsely elevated ammonia (amm) patient result obtained on a dimension vista 1500 system.Siemens is investigating the event.
Event or Problem Description
A discordant, falsely elevated ammonia (amm) result was obtained on a patient sample on a dimension vista 1500 system.The discordant result was reported to the physician.The patient was transferred to another hospital facility and a new sample was processed on an alternate non-siemens instrument.A lower result was obtained and reported.The customer stated that the patient was sent to the alternate hospital due to the discordant, falsely elevated amm result.There are no known reports of adverse health consequences to the patient due to the discordant amm result or due to the transfer to the hospital.
Additional Manufacturer Narrative
Initial mdr 2517506-2021-00082 was filed (b)(6) 2021.Additional information ((b)(6) 2021): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely elevated ammonia (amm) results.Hsc reviewed the information provided by the customer and the instrument data files.Quality control was in range and no similar events were reported with other patient samples indicating that the instrument and assay were performing acceptably.A potential product issue has not been identified.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section e1 has been updated to show the correct initial reporter name, ziekenuis bernhoven.Section h6 has been updated to reflect the hsc investigation.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA® AMM AMMONIA FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 11519038
• Report Number: 2517506-2021-00082
• Device Sequence Number: 3678759
• Product Code: JIF
• UDI-Device Identifier: 00630414948102
• UDI-Public: 00630414948102
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K123677
• 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): 04/16/2021

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: 07/29/2021
• Device Model Number: 10711992
• Device Catalogue Number: K3119 SMN 10711992
• Device Lot Number: 20211BA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1