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

Catalog Number K1137 SMN 10445163

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

Mdr 2517506-2019-00412 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 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 the same day and reprocessed on a later date on a non-siemens blood gas analyzer methodology and higher correct results were obtained and reported.There are no reports of patient intervention or adverse health consequence due to the discordant falsely depressed co2 result.

Manufacturer Narrative

Mdr 2517506-2019-00410 was filed on (b)(6) 2019.Mdr 2517506-2019-00412 was filed for the same event.Additional information (b)(6) 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®
• Type of Device: 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: 9241251
• MDR Text Key: 190691737
• Report Number: 2517506-2019-00410
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00842768015625
• UDI-Public: 00842768015625
• Combination Product (y/n): N
• PMA/PMN Number: K061238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR