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

Catalog Number K3105A

Device Problems False Device Output (1226); Nonstandard Device (1420); High Test Results (2457)

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

Event Date 05/16/2014

Event Type  malfunction  

Event Description

Biased high hba1c results were obtained on (b)(4) samples.It is unknown if patient treatment was altered or prescribed on the basis of the biased high hba1c results.There was no report of adverse health consequences as a result of the biased high hba1c results.

Manufacturer Narrative

Siemens healthcare diagnostics has confirmed that the dimension vista® hba1c flex® reagent cartridge lots 13294ba, 13308ba, 13329aa, 13350aa, 14006aa, 14041ba, 14069bb, and 14083ba exhibit a positive bias averaging 0.4% hemoglobin a1c units and occasionally up to 1.0% hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp).Qc samples may exhibit a similar bias.This bias resulted in complaints for (b)(4) failures.In the urgent medical device recall letter dated september 2014, #14-52 issued to customers who were shipped the impacted lots, siemens directed customers to discontinue use and to discard the impacted lots.Siemens stated it would replace any unused inventory of the affected lots at no charge with a non-affected lot.

• Brand Name: DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM
• Type of Device: HEMOGLOBIN A1C
• 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: 4137556
• MDR Text Key: 19762047
• Report Number: 2517506-2014-00278
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102045
• 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: Recall
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 11/15/2014
• Device Catalogue Number: K3105A
• Device Lot Number: 13350AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2517506-10-03-2014-008-C
• Patient Sequence Number: 1