MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION(R) CLINICAL CHEMISTRY SYSTEM; HEMOGLOBIN A1C KIT

Catalog Number DF105A

Device Problem High Test Results (2457)

Patient Problem No Information (3190)

Event Date 09/19/2015

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the falsely elevated hb1c results is user error.The account failed to input the correct lot specific scaler values.The siemens healthcare diagnostics customer care center performed reagent calibration data analysis and informed the customer of their incorrect scaler entry.The issue was resolved by entering correct scaler values, recalibrating, and verifying with qc.The hb1c flex reagent cartridge df105a instructions for use clearly state: hb1c requires lot-specific scalers which must be entered in the calibration set up screen, prior to calibration.The scaler values are provided on the flex reagent cartridge carton.These scalers are applied to all qc and patient results to maintain accuracy.Failure to enter the lot-specific scalers will cause inaccurate results.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

Falsely elevated hb1c results were obtained on qc and patient samples after calibration.The patient results were reported to physicians.After qc values were detected out of laboratory ranges and subsequent investigation, it was determined that an incorrect scaler value had been entered.It is unknown if patient treatment was altered or prescribed on the basis of the falsely elevated hb1c results.There was no report of adverse health consequences as a result of the falsely elevated hb1c results.

• Brand Name: DIMENSION(R) CLINICAL CHEMISTRY SYSTEM
• Type of Device: HEMOGLOBIN A1C KIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• 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: 5140375
• MDR Text Key: 27934324
• Report Number: 2517506-2015-00204
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 04/10/2016
• Device Catalogue Number: DF105A
• Device Lot Number: GC6101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1