MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

Model Number ADVIA 1800

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant, falsely elevated cre_2c results on patient samples is unknown.Siemens is investigating the issue.

Event Description

The customer obtained discordant, falsely elevated concentrated creatinine (cre_2c) results on patient samples on four advia 1800 instruments, while using an unknown reagent lot.The samples were repeated on the same instruments, which resulted lower.The discordant results were not reported to the physician(s).It is unknown if the repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated cre_2c results.

Manufacturer Narrative

The initial mdr 2432235-2017-00122 was filed on february 14, 2017.Additional information (04/13/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer.Quality controls were within acceptable range.The hsc specialist stated that the issue may have been caused due to the poor alignment of reagent probe 1 (rpp1) or first reagent (r1) or sample delivered onto the wall of reaction bath oil (rrv), which can reduce the absorbance.The hsc specialist recommended the customer to ensure that the rpp1 and sample drains are working properly.The hsc specialist also recommended checking that the oil in the rrv is not cloudy, verifying the mixer operation and ensuring that the oil in the reaction tank level is not over flowing and the mix wash stations are working properly.The cause of the discordant, falsely elevated cre_2c results on patient samples is unknown.Siemens is investigating the issue.

Manufacturer Narrative

The initial mdr 2432235-2017-00122 was filed on february 14, 2017.The first supplemental mdr 2432235-2017-00122 was filed on may 8, 2017.Additional information (04/13/2017): a siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse replaced the clot detector and valves.After the service visit, the customer did not obtain additional discordant results.The instrument is performing within manufacturing specifications.No further evaluation of device is required.Corrected information (07/18/2017): the initial mdr states that the customer obtained discordant, falsely elevated concentrated creatinine (cre_2c) results on patient samples on four advia 1800 instruments, while using an unknown reagent lot.The customer had stated that all four advia 1800 systems showed issues.However, it is unknown if they obtained discordant results for the other systems except for s/n: (b)(4).

Event Description

The customer obtained discordant, falsely elevated concentrated creatinine (cre_2c) results on patient samples on an advia 1800 instrument.The samples were repeated on the same instrument, which resulted lower.

• Brand Name: ADVIA 1800
• Type of Device: ADVIA 1800
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; registration #: 3003637681; 3-1-2 musashino akishima; tokyo 196-8 558; JA 196-8558
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 6330444
• MDR Text Key: 67657575
• Report Number: 2432235-2017-00122
• Device Sequence Number: 0
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 1800
• Device Catalogue Number: 06860515
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided; 04/13/2017
• Supplement Dates FDA Received: 05/08/2017; 07/18/2017
• 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: Reuse
• Patient Sequence Number: 1