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 Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) about discordant carbon dioxide (co2) results obtained on a grossly lipemic patient sample on a dimension vista 500 instrument.Siemens headquarters support center (hsc) evaluated the instrument data and completed the investigation of the event.No instrument process errors were observed.The customer did not report issues with any other assays on the instrument.Co2 quality control was within the laboratory acceptable ranges.No product non-conformance was identified with the instrument or assay.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.

Event Description

Discordant carbon dioxide (co2) patient results were obtained on a grossly lipemic patient sample when processed on a dimension vista 500 system.The sample was centrifuged again and reprocessed.The original and repeat results after additional centrifugation of the sample were reported to the physician(s) and were questioned.A whole blood sample from the same patient was processed on the same day with an alternate methodology and a corrected co2 result was reported to the physician.There are no reports of patient intervention or adverse health consequence due to the discordant co2 results.

• 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; p.o. box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 8992808
• MDR Text Key: 159784544
• Report Number: 2517506-2019-00347
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00842768015625
• UDI-Public: 00842768015625
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2019

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: 05/29/2020
• Device Catalogue Number: K1137 SMN 10445163
• Device Lot Number: 19150BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR