MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA®; DIMENSION VISTA® CO2 CARBON DIOXIDE FLEX® REAGENT CARTRIDGE

Catalog Number	K1137 SMN 10445163
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2019-00410 was also filed for the same event.The customer contacted the siemens customer care center (ccc) and reported a discordant depressed carbon dioxide (co2) patient result was obtained on a dimension vista 500 instrument.Siemens healthcare diagnostics headquarters support center (hsc) is investigating the event.
Event or Problem Description
A discordant falsely depressed carbon dioxide (co2) patient result was obtained on a dimension vista 500 instrument.The initial result was reported to the physician(s) who questioned the result.The same sample was reprocessed at an alternate facility on an alternate dimension vista instrument and the original low result was confirmed.A new patient sample was drawn at an alternate facility and processed on a later date on a non-siemens blood gas analyzer methodology and a higher correct result was obtained and reported.There are no reports of patient intervention or adverse health consequence due to the discordant falsely depressed co2 result.
Additional Manufacturer Narrative
Mdr 2517506-2019-00412 was filed on 25-oct-2019.Mdr 2517506-2019-00410 was filed for the same event.Additional information (24-oct-2019): the customer confirmed that a result of <5 mmol/l was obtained on a non-siemens alternate enzymatic co2 methodology for patient sample identification numbers (sids) 1306851 and 1307434.Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely depressed carbon dioxide (co2) results.Hsc evaluated the information provided and the instrument data files.Samples from the patient were provided.Siemens technical support laboratory (tsl) internal testing of the samples was inconclusive for the cause of the depressed dimension vista co2 results.No product problem was identified.The cause of this 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® CO2 CARBON DIOXIDE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 9241249
• Report Number: 2517506-2019-00412
• Device Sequence Number: 132989
• Product Code: KHS
• UDI-Device Identifier: 00842768015625
• UDI-Public: 00842768015625
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K061238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 03/04/2020
• Device Catalogue Number: K1137 SMN 10445163
• Device Lot Number: 19064BA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 78 YR