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

Model Number ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/29/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer reported that they obtained out of range quality control results and discordant results on patient samples when changing from one pair of iron_2 reagent 1 and reagent 2 over to the second pair of the onboard reagents.The customer performed calibration and reran the patient samples, which were lower.The cause of the discordant, falsely elevated iron_2 results on two patient samples is unknown.Siemens is investigating the issue.

Event Description

The customer obtained discordant, falsely elevated iron_2 results on two patient samples on an advia 2400 instrument, when using reagent kit lot 139.The customer repeated the calibration and the patient samples on the same instrument and the patient sample results were lower.The initial results were reported to the physician(s).The repeat results were reported as corrected results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated iron_2 results.

Manufacturer Narrative

The initial mdr 2432235-2017-00077 was filed on january 24, 2017.Corrected information (01/27/2017): the initial mdr stated that the advia chemistry iron_2 reagents (iron_2) kit lot # was 139.The correct kit lot # is 383073.

Event Description

The customer obtained discordant, falsely elevated iron_2 results on two patient samples on an advia 2400 instrument, when using reagent kit lot 383073.The customer repeated the calibration and the patient samples on the same instrument and the patient sample results were lower.The initial results were reported to the physician(s).The repeat results were reported as corrected results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated iron_2 results.

Manufacturer Narrative

The initial mdr 2432235-2017-00077 was filed on january 24, 2017.The first supplemental mdr 2432235-2017-00077_s1 was filed on january 27, 2017.Additional information (02/13/2017): the customer stated that they have now been mixing reagents prior to placing them on-board.A siemens headquarters support center (hsc) specialist reviewed the data provided by the customer.The hsc specialist stated that there is no known reason for an impact on results by mixing.The hsc specialist stated that there was no reagent issue.The cause of the discordant, falsely elevated iron_2 results on two patient samples is unknown.The device is performing as intended.

Manufacturer Narrative

The initial mdr 2432235-2017-00077 was filed on january 24, 2017.The first supplemental mdr 2432235-2017-00077_s1 was filed on january 27, 2017.The second supplemental mdr 2432235-2017-00077_s2 was filed on march 10, 2017.Additional information (03/29/2017): the customer stated that the patient samples were also impacted on two additional advia chemistry instruments.The customer did not provide patient data.

• Brand Name: ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2)
• Type of Device: ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin, co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 6274084
• MDR Text Key: 66031950
• Report Number: 2432235-2017-00077
• Device Sequence Number: 1
• Product Code: CIX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K991576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2)
• Device Lot Number: 383073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1