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

Catalog Number K3105A

Device Problems Nonstandard Device (1420); High Test Results (2457)

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

Event Date 07/15/2014

Event Type  malfunction  

Event Description

Biased high hba1c results were obtained on (b)(6) survey 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

(b)(4).Qc samples may exhibit a similar bias.This bias resulted in complaints for (b)(6) survey 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.

Manufacturer Narrative

Original mdr was submitted 09/30/2014.As a result of investigations, siemens 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 college of american pathologists (cap) survey 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) 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: 4111022
• MDR Text Key: 4716981
• Report Number: 2517506-2014-00348
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 10/04/2014
• Device Catalogue Number: K3105A
• Device Lot Number: 13308BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2517506-10/03/2014-008-C
• Patient Sequence Number: 1