MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 XPI

Model Number IMMULITE 2000 XPI

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

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

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) visited the customer site.The cse ran water test and the results were within specifications.The cse checked all sample and reagent probe positions.The cse checked the shaker bars in the luminometer and the incubator, verified the wash and dilution speeds, checked the vacuum and the function of the dual resolution diluters.The substrate tubing was found to have a curve, instead of being flat, at the subatrate bottle.The cse fixed the tubing and checked the water and substrate pump volumes.The cse ran quality control (qc) materials to verify the performance of the instrument.A siemens headquarter support center (hsc) specialist reviewed the instrument files.Review of the instrument data indicated that only one sample was aspirated from the sample tube.In this scenario, the instrument files cannot indicate if the presence of bubbles in the sample could have caused the discordant, falsely low result.There were no level sense issues or mechanical issues detected that could have caused the discordant, falsely low result.There are no additional reports of falsely low discordant results since the cse visit.The hsc specialist indicated that pre-analytical factors or sample specific issues may contribute to discordant results.The cause of the discordant, falsely low gi-ma (ca19-9) result on the immulite 2000 xpi instrument is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely depressed gi-ma (ca19-9) result was obtained on an immulite 2000 xpi instrument from one patient sample.The same sample was repeated on the same instrument, resulting, higher.The higher result was in alignment with the historical gi-ma (ca19-9) levels of the patient.It is unknown if the initial or 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 depressed gi-ma (ca19-9) result.

• Brand Name: IMMULITE 2000 XPI
• Type of Device: IMMULITE 2000 XPI
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd.; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders NJ 07836
• Manufacturer Contact: devyani chaudhuri ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242637
• MDR Report Key: 8400600
• MDR Text Key: 139241640
• Report Number: 2247117-2019-00016
• Device Sequence Number: 1
• Product Code: LGD
• UDI-Device Identifier: 00630414945422
• UDI-Public: 00630414945422
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K970227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2019

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
• Device Operator: Other
• Device Model Number: IMMULITE 2000 XPI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/07/2019
• 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
• Patient Age: 69 YR