MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

Model Number ADVIA 2400

Device Problem Mechanical Problem (1384)

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

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report the discordant glucose hexokinase_3 result.Quality control (qc) was within range.A siemens customer service engineer (cse) was dispatched to the customer site.The service was performed over multiple visits.The cse performed adjustment of aspiration probe.The cse observed reaction cuvette washers (wud) needed cleaning.The cse performed cleaning of wud probes.The cse replaced clot sensor.A siemens headquarters support center (hsc) reviewed the information provided and concluded the event is not due to a reagent lot or method issue.The data is consistent with instrument related issues with the potential cause being the clogging of wud probes.Improper washing of the reaction tray (rrv) cuvettes due to the clogged detergent and aspiration lines on the wud is consistent with imprecision issues.The cause of the discordant glucose hexokinase_3 result is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.Mdr 2432235-2017-00550 was filed for the same event.Mdr 2432235-2017-00553 was filed for the same event.

Event Description

Discordant, glucose hexokinase_3 results were obtained on patient samples on an advia 2400 instrument.The discordant results were not reported to the physician(s).The samples were repeated on the same instrument.The repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant glucose hexokinase_3 results.

Manufacturer Narrative

The initial mdr 2432235-2017-00554 was filed on oct 13, 2017.Additional information (10/23/2017): the customer service engineer (cse) changed and aligned the liquid level sensor.The cse ran 1600 samples and one sample resulted with an error, however this sample had bubbles.The customer was to check the pre analytical sample factors.The cause of the discordant results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.Mdr 2432235-2017-00550_s1 was filed for the same event.Mdr 2432235-2017-00553_s1 was filed for the same event.

• Brand Name: ADVIA 2400
• Type of Device: ADVIA 2400
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; registration#: 3003637681; tokyo, 196-8 558; JA 196-8558
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6948214
• MDR Text Key: 90306949
• Report Number: 2432235-2017-00554
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K990346
• 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
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 2400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1