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

Model Number ADVIA 1800

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

Patient Problem Misdiagnosis (2159)

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant creatinine results is unknown.Siemens is investigating this issue.

Event Description

Discordant creatinine results were obtained on two patient samples on an advia 1800 instrument.The initial results were reported to physician(s), who questioned the results.The samples were repeated and a corrected report was issued to physician(s).The initial and repeat testing was performed with the same sample and on the same instrument.Dialysis was performed on one patient due to the discordant creatinine results.There are no reports of adverse health consequences due to the discordant creatinine results.

Manufacturer Narrative

The initial mdr 2432235-2017-00198 was filed on march 17th, 2017.Additional information (03/20/2017): a siemens customer care center (ccc) specialist followed up with customer and obtained additional information on the patient samples and the lot number of the reagent used.Other relevant history and model #/lot # have been updated with this additional information.The ccc specialist confirmed that calibrations and quality control materials were in range at the time of testing and there were no error messages associated with the discordant results.

Manufacturer Narrative

The initial mdr 2432235-2017-00198 was filed on march 17th 2017.A follow up mdr 2432235-2017-00198_s1 was filed on april 7th 2017.Additional information (may 5th 2017): a siemens headquarter support center (hsc) specialist reviewed the information and stated that the various probes and probe parameters on the instrument should be checked, including the wash wells.In addition, the wash station and the reagent 1 (r1), reagent 2 (r2) mix should also be checked.The hsc specialist also noted that the sample tubes used by the customer were greiner serum separator gel tubes.The centrifugation requirements for greiner tubes are different from other tubes such as becton-dickinson vacutainer tubes and that manufacturer's recommendations should be followed while centrifuging the tubes.Additional information (may 23rd 2017): a siemens customer care center (ccc) specialist followed up with the customer.The customer is no longer using the advia 1800 instruments.The cause of the discordant creatinine results is unknown.No further investigation of the device is required.

• Brand Name: ADVIA 1800
• Type of Device: ADVIA 1800
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; registration # 3003637681; 3-1-2 musashino akishima; tokyo, 96-85 58; JA 96-8558
• Manufacturer Contact: devyani chaudhuri ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242637
• MDR Report Key: 6414668
• MDR Text Key: 70332959
• Report Number: 2432235-2017-00198
• Device Sequence Number: 0
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: ADVIA 1800
• Device Lot Number: 383087
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• 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: Reuse
• Patient Sequence Number: 1