MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY HEMOGLOBIN A1C_3 REAGENTS

Model Number ADVIA CHEMISTRY HEMOGLOBIN A1C_3 REAGENTS

Device Problems Nonstandard Device (1420); Low Test Results (2458); Device Ingredient or Reagent Problem (2910)

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

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has confirmed the hemoglobin a1c_3/ a1c_3m reagent kit lots 230 (smn10379673 and 10485591) and 231( smn 1048559) used on the advia® 1200, 1650, 1800, 2400, and xpt chemistry systems may demonstrate an increased occurrence of high %hba1c bias.Siemens internal investigation demonstrates reagent lots 230 and 231 may exhibit a positive bias averaging 0.6% hba1c units, ranging from -0.1% to 1.1% hba1c units.The bias was observed when comparing %hba1c means to ngsp pooled patient target-value assigned samples ranging from approximately 5.5% to 8.0% hba1c.The maximum bias was observed at higher %hba1c concentrations.Qc samples may exhibit a similar bias.An urgent medical device correction (umdc) chc-15-19 is being sent to us customers and a urgent field safety notice (ufsn) chc-15-19 is being sent to ous customers in september of 2015.The umdc and ufsn state that customers are to discontinue use and discard reagent kit lots 230 and 231.

Event Description

The customer has indicated that they are noticing a low bias on quality control samples for the hemoglobin a1c_3 assay on the advia chemistry 1800 instrument when using reagent lot 231.There were no reports of patient intervention or adverse health consequences due to the low bias on quality control samples.

Manufacturer Narrative

Initial mdr 2432235-2015-00434 was filed on 9/25/2015.Additional information (9/30/2015): the correction/removal report (crr) was provided to the fda on 9/30/2015.

• Brand Name: ADVIA CHEMISTRY HEMOGLOBIN A1C_3 REAGENTS
• Type of Device: ADVIA CHEMISTRY HEMOGLOBIN A1C_3 REAGENTS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS (REF#2517506); 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 5102842
• MDR Text Key: 26856691
• Report Number: 2432235-2015-00434
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ADVIA CHEMISTRY HEMOGLOBIN A1C_3 REAGENTS
• Device Catalogue Number: 10379673, 10485591
• Device Lot Number: 231
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2517506-09/30/2015-007-R
• Patient Sequence Number: 1