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

Model Number ADVIA CHEMISTRY A1C_3 CALIBRATOR

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

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

Event Date 04/07/2014

Event Type  malfunction  

Event Description

The customer has observed high patient bias on one patient sample for the a1c_3 assay on an advia 1800 instrument when using calibrator lot 3ld068.The patient sample was run on the advia 1800 instrument and then repeated twice on an alternate platform.The results obtained on the advia and the alternate platform were above the reference range set by the customer for the assay.The patient was then redrawn and the sample was sent to another site and run on another alternate platform and the result was lower.There were no reports of patient intervention or adverse health consequences due to the high bias observed on the one patient sample for the a1c_3 assay.

Manufacturer Narrative

Siemens has confirmed that the advia chemistry systems a1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (hb)a1c samples when using a1c_3 calibrator lots 3hd044 and 3ld068.Depending on quality control limits, this issue may not have been detected.An urgent medical device recall (umdr) 10819262, rev.A was sent to us customers and an urgent field safety notice (ufsn) 10819261, rev.A was sent to ous customers in august of 2014.The umdr and ufsn state that customers are requested to discontinue use of and discard the calibrator lots listed, and to review the physician's letter sent along with the umdr and ufsn with their medical director.

Manufacturer Narrative

The original mdr 2432235-2014-00435 was filed on august 7, 2014.Corrected information (08/25/14):section updated with the correct 510k number k081895.

Manufacturer Narrative

The original mdr 2432235-2014-00435 was filed on august 7, 2014.The first follow up report was filed on september 3, 2014.Additional information (12/19/14): final root cause: bias in patient sample and (b)(4) survey performance was not detected due to the insensitivity in the calibrator and reagent testing control system.The overall capability (error budget) of a1c_3 method was not sufficient to consistently provide clinically acceptable results across all reagent and calibrator lots.A key component of the error budget is the manufacturing controls system for assignment of the calibrator bottle values where the inaccuracy of this process is due to lack of statistical power.

• Brand Name: ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
• Type of Device: ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS (REG# 2517506); 500 gbc drive; p.o. box 6101; newark DE 19714 610
• Manufacturer Contact: mindy losapio ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242312
• MDR Report Key: 3986380
• MDR Text Key: 4818154
• Report Number: 2432235-2014-00435
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081895
• 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,Followup
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ADVIA CHEMISTRY A1C_3 CALIBRATOR
• Device Catalogue Number: 10491408
• Device Lot Number: 3LD068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2014
• 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: 2432235-08/04/14-002-R
• Patient Sequence Number: 1