MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2)

Model Number	ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and stated that they noted more than usual numbers for low iron_2 results in the centralink validation queue.The customer ran quality control, which was out of range.The customer believes that the issue occurred after they changed the reagent bottle.The customer calibrated the assay and reran quality controls, which were within acceptable range.The customer repeated the patient samples post calibration and obtained acceptable results.The customer stated that the issue was resolved by having one pair of reagent on board at a time and inverting it several times before placing it on board.As per the advia chemistry iron_2 instructions for use, "siemens recommends calibrating new reagent packs if the previous reagent pack was recalibrated any time during its on-board stability, other than as a fresh pack." the customer does not follow this recommendation.Additionally, the customer does not always mix reagents when placed on-board.A siemens headquarters support center (hsc) specialist reviewed the information provided and stated that the data showed a constant bias between initial and repeat results, indicating calibration issue with an open vial of reagent.The hsc specialist stated that this issue was not due to reagent issue.The hsc specialist concluded that the issue may have occurred due to difference in performance with a partially used vial versus a fresh vial which can impact calibrator recovery.The cause of the discordant, falsely low iron_2 results on one patient sample is unknown.The device is performing within manufacturing specifications.No further evaluation of device is required.
Event or Problem Description
The customer obtained discordant, falsely low iron_2 results on multiple patient samples on an advia 2400 instrument, while using reagent kit lot # 393998.The samples were repeated on the alternate advia chemistry instruments, resulting higher.The initial results for sample ids (b)(6) were reported to the physician(s).The corrected results for sample ids (b)(6) were reported to the physician(s).It is unknown which results were reported for sample ids (b)(6).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low iron_2 results.

• Brand Name: ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2)
• Common Device Name: ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 6661581
• Report Number: 2432235-2017-00379
• Device Sequence Number: 71984
• Product Code: CIX
• UDI-Device Identifier: 00630414561974
• UDI-Public: 00630414561974
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K991576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2)
• Device Lot Number: 393998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1