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

Model Number ADVIA CHEMISTRY HEMOGLOBIN A1C_3 REAGENT

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens field service engineer (fse) visited the customer site and did not find any instrument related issues, the cause of the imprecision on the patient sample for the hemoglobin a1c_3 assay is unknown.Siemens is investigating this issue.

Event Description

The customer is observing imprecision on patient samples for the hemoglobin a1c_3 assay on the advia chemistry 1800 instrument when using reagent lot 231.The initial and the repeat results on the patient sample did not match.As per laboratory protocol all samples >8%, that are not repeatable are sent to a reference lab for confirmation.It is unknown if patient sample results were reported to the physician(s).There were no reports of adverse health consequences due to the imprecision for hemoglobin a1c_3.

Manufacturer Narrative

Initial mdr 2432235-2015-00384 was filed on 9/4/2015.Follow up report mdr 2432235-2015-00384_s1 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.

Manufacturer Narrative

Initial mdr 2432235-2015-00384 was filed on 9/4/2015.Additional information (9/22/2015): 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.

• Brand Name: ADVIA CHEMISTRY HEMOGLOBIN A1C_3 REAGENT
• Type of Device: ADVIA CHEMISTRY HEMOGLOBIN A1C_3 REAGENT
• 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: 5057462
• MDR Text Key: 26124864
• Report Number: 2432235-2015-00384
• 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
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• 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 REAGENT
• Device Catalogue Number: 10379673
• Device Lot Number: 231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2517506-09/30/2015-007-R
• Patient Sequence Number: 1