MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA; DIMENSION VISTA® (ECREA) ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE

Model Number	10700444
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdrs 2517506-2021-00022, 2517506-2021-00023, 2517506-2021-00024, 2517506-2021-00026 and 2517506-2021-00027 were filed for the same event.The customer contacted the siemens customer care center (ccc) concerning discordant, falsely depressed enzymatic creatinine (ecrea) results on dimension vista 1500 system.Siemens is investigating the event.
Event or Problem Description
Discordant, falsely depressed patient sample results were obtained for enzymatic creatinine (ecrea) on a dimension vista 1500 system.The results were reported to the physician(s).The same samples were reprocessed after an adjustment to the digits of precision setting on the instrument and higher results were obtained.Corrected results were reported.There are no known reports of patient intervention or adverse health consequences due to the discordant ecrea results.
Additional Manufacturer Narrative
Initial mdrs 2517506-2021-00022, 2517506-2021-00023, 2517506-2021-00024, 2517506-2021-00025, 2517506-2021-00026 and 2517506-2021-00027 were filed for the same event on (b)(60 2021.Additional information ((b)(6) 2021): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely depressed enzymatic creatinine (ecrea) results on a dimension vista 1500 system.Hsc evaluated the information provided and the instrument data files.A siemens customer service engineer (cse) determined that the customer had processed patient samples after changing the digits of precision setting for the ecrea assay method configuration.The incorrect setting caused the ecrea sample results to be either rounded up or down to the nearest 10 or 100.The cse evaluated the system and returned the digits of precision to the correct setting of 3 which restored the system to standard operation.Quality control was within the expected range after restoring the digit of precision setting.No issues were noted with other patient samples indicating that the instrument and assay were performing acceptably.The cause of the event is use error.A potential product issue was not identified.The device is performing within specifications.No further evaluation is required.Section g1 has been updated to reflect the hsc investigation.Section h6 has been updated to reflect the hsc investigation.Mdr supplements 2517506-2021-00022 supplement 1, 2517506-2021-00023 supplement 1, 2517506-2021-00024 supplement 1, 2517506-2021-00026 supplement 1 and 2517506-2021-00027 supplement 1 were filed for the same event.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA® (ECREA) ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 11209252
• Report Number: 2517506-2021-00025
• Device Sequence Number: 20023508
• Product Code: JFY
• UDI-Device Identifier: 00842768036262
• UDI-Public: 00842768036262
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090330
• 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): 02/11/2021

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: 07/20/2021
• Device Model Number: 10700444
• Device Catalogue Number: K1270A SMN 10700444
• Device Lot Number: 20232AA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1