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

Catalog Number DF105A

Device Problem High Readings (2459)

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

Event Date 02/12/2014

Event Type  malfunction  

Event Description

Biased high hb1c results were obtained on qc and patients after calibration.Patient results were reported to the physicians who questioned the results.After investigation, it was determined that incorrect calibration scaler values had been entered.Scaler values were corrected and lower qc and patient results were obtained and patient reports were corrected.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.

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the biased high hb1c results is user error.The account failed to input the correct lot specific scalers for the new lot of hb1c reagent.The falsely elevated results were caused by using the incorrect scalers and the issue was resolved by entering correct scalers, recalibrating, and verifying by qc.The hb1c method uses an additional parameter called scaler values.These values are polynomial equation factors that have been determined for hb1c in order to provide the best correlation to the hba1c reference methodology.This feature was communicated to customers with the launch of hb1c (df105a) in the hb1c kit supplement.Siemens healthcare diagnostics inc.Issued an urgent medical device correction, communication (b)(4), in august 2012 to reinforce instructions to customers to enter and verify scalers with every calibration of new hb1c flex(r) reagent cartridge lots and with each recalibration of the same flex lot.Siemens records confirm that the communication was distributed to the account.The instrument is performing within specifications.No further evaluation of the device is required.

• 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 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19702
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 3640543
• MDR Text Key: 4208739
• Report Number: 2517506-2014-00039
• 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 Facility
• Reporter Occupation: Medical Technologist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/12/2014

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: Medical Technologist
• Device Expiration Date: 12/16/2014
• Device Catalogue Number: DF105A
• Device Lot Number: GA4350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2517506-08-29-2012-013-C
• Patient Sequence Number: 1