MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA (R) CLINICAL CHEMISTRY SYSTEM; GLUCOSE FLEX® REAGENT CARTRIDGE

Catalog Number K1039

Device Problems Low Test Results (2458); Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2014

Event Type  malfunction  

Event Description

Falsely depressed glucose results were obtained on a group of patient samples.The results were reported to the physicians who questioned the results.After investigation, it was determined that a bad calibration had been accepted as evidenced by qc out of laboratory ranges.Corrected patient results were issued after proper recalibration as verified by within range qc.It is unknown if patient treatment was altered or prescribed on the basis of the falsely depressed glucose results.There was no report of adverse health consequences as a result of the falsely depressed glucose results.

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the falsely depressed glucose results is user error.The account accepted a bad calibration which was detectable by qc.Samples were reported before the qc bias was noted.The issue was resolved by recalibration with properly handled new calibrator and confirmation by qc.Corrected results were issued.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION VISTA (R) CLINICAL CHEMISTRY SYSTEM
• Type of Device: GLUCOSE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 3595521
• MDR Text Key: 4167437
• Report Number: 2517506-2014-00031
• Device Sequence Number: 1
• Product Code: CFR
• 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 Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 01/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 05/17/2014
• Device Catalogue Number: K1039
• Device Lot Number: 13137AD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1