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

Model Number DIMENSION RXL MAX WITH HM

Device Problem Mechanical Problem (1384)

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

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a (b)(4) customer care center (ccc) specialist.The ccc reviewed the data provided.The customer's quality control (qc) was in range at the time of the event.A (b)(4) customer service engineer (cse) was dispatched to the customer's site.The cse checked all ultrasonic voltages, resulting within specification.The cse verified the wash probe, sample probe and reagent 2 probe alignments and adjusted probes.The cse calibrated the heterogeneous module mixers.The cse found material in the wash station tubing 2 and 4.The cse replaced the wash stating tubing, primed and ran 5 repetitions precision for qc levels 1 and 2, resulting within range.The cause of the discordant, discordant, falsely elevated free thyroxine result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated free thyroxine result was obtained on a patient sample on a dimension rxl max with hm instrument.The initial result was reported out to the physician(s), which was questioned.The customer redrew a sample and tested it on the same dimension rxl max with hm instrument, resulting lower.The customer issued a corrected report to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated free thyroxine result.

• Brand Name: DIMENSION RXL MAX WITH HM
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6437867
• MDR Text Key: 70984962
• Report Number: 2517506-2017-00321
• 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
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION RXL MAX WITH HM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2009
• 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