MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION XPAND PLUS WITH HM; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION XPAND PLUS WITH HM

Device Problem Mechanical Problem (1384)

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

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Upon the ccc specialist's instructions, the customer replaced the reagent 2 probe and observed a reagent preparation error.The customer then cleaned the reagent drains, changed the source lamp and performed precision testing, which was acceptable.The ccc specialist recommended the customer to follow proper tube manufacturing instructions for centrifugation time and speed.The customer stated that the imprecision had returned.A siemens customer service engineer (cse) was dispatched to the customer site.After evaluating the instrument, the cse decontaminated the instrument and primed the pumps.The cse checked the millipore reservoir and found that no air was coming out of the defuser.The cse replaced the air pump as it had malfunctioned however, the air was still not bubbling as the defuser and tank were contaminated with black mold.The cse ran a chemistry wash test and the customer calibrated ltni.The millipore was decontaminated.The cse re-visited the customer site and performed extended decontamination procedure on the instrument and reran the chemistry wash.A siemens headquarters support center specialist reviewed the instrument data and the service report.The instrument data did not indicate a product issue.The hsc specialist stated that the patient data for the discordant ft4 result was consistent with a sample specific issue.The cause of the discordant, falsely low ft4 result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely low free thyroxine (ft4) result was obtained on one patient sample on a dimension xpand plus with hm instrument.The discordant result was not reported to the physician(s).The sample was repeated several times on the same instrument, resulting higher each time.One of the repeat results was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low ft4 result.

Manufacturer Narrative

The initial mdr 2517506-2017-00208 was filed on 02-mar-2017.

• Brand Name: DIMENSION XPAND PLUS WITH HM
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: shweta gulati ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242870
• MDR Report Key: 6372560
• MDR Text Key: 68976488
• Report Number: 2517506-2017-00208
• Device Sequence Number: 0
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION XPAND PLUS WITH HM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2002
• 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