MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® GLUCOSE FLEX® REAGENT CARTRIDGE

Catalog Number K1039 SMN 10445162

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed glucose result.The customer noted that the sample had a black discoloration.This was the only sample with this issue.The customer processed other samples without issue.Quality control (qc) was reprocessed after this patient sample and it was within laboratory ranges.Hsc concluded that this is not a reagent lot or assay issue.There is no evidence of a product nonconformance.There was no indication of foaming or reagent delivery issues based on the instrument data files.A siemens customer service engineer (cse) was dispatched to the customer account.Product maintenance was performed and no further discordant glucose results were observed.The device is performing within specifications.No further evaluation is required.

Event Description

A discordant, falsely depressed glucose (glu) result was obtained on a patient sample on the dimension vista 500 system.The discordant result was not reported to the physician.The same sample was reprocessed the same day with an alternate, non-siemens methodology and a higher result was obtained and reported.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed glucose result.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® GLUCOSE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po 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 ; 3026318356
• MDR Report Key: 8316925
• MDR Text Key: 138140965
• Report Number: 2517506-2019-00036
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 00842768015663
• UDI-Public: 00842768015663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061655
• 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: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2019
• Device Catalogue Number: K1039 SMN 10445162
• Device Lot Number: 18262BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2018
• 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