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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) concerning a discordant, falsely depressed enzymatic creatinine (ecrea) result on a dimension vista 500 system.Siemens is investigating the event.
Event or Problem Description
A discordant, falsely depressed patient sample result was obtained for enzymatic creatinine (ecrea) on a dimension vista 500 system.The result was reported to the physician(s).The same sample was reprocessed after a recalibration of the assay and a higher ecrea result, considered correct, was obtained.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed ecrea result.
Additional Manufacturer Narrative
Initial mdr 2517506-2021-00048 was filed 03-feb-2021.Additional information (09-feb-2021): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely depressed enzymatic creatinine result.Hsc evaluated the information provided and the instrument data files.The event was resolved with recalibration from a new flex well set.Quality control was in range upon recalibration and testing from subsequent new flex reagent wells.No similar events were noted with other patient samples indicating that the instrument and assay were performing acceptably.Repeat of the same sample yielded an expected result.A potential product issue was not 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® (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: 11273410
• Report Number: 2517506-2021-00048
• Device Sequence Number: 4997699
• Product Code: JFY
• UDI-Device Identifier: 00842768036262
• UDI-Public: 00842768036262
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 02/25/2021

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: 12/27/2020
• Device Model Number: 10700444
• Device Catalogue Number: K1270A SMN 10700444
• Device Lot Number: 20027AC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR