MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL MAX WITH HM; DIMENSION® RXL MAX WITH HM

Model Number DIMENSION® RXL MAX WITH HM

Device Problem Mechanical Problem (1384)

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

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported discordant tacrolimus results on patient samples.Calibrations and quality controls (qc) were within acceptable range.A siemens customer service engineer was dispatched to the customer site.Upon the regional support center (rsc) specialist's recommendations, the following troubleshooting steps were performed: system check and diagnostic test for photometer alignment were run, lamp calibration values were verified, reagent 1 (r1), reagent 2 (r2) and sample probes alignments to vessel points were checked, and ultrasonic performance for the probes were verified.The customer ran precision testing, which was acceptable.Upon the rsc specialist's recommendation, the cse replaced the vessel feeder.The cse found that the customer mixes sample by hand.A siemens headquarter support center (hsc) specialist reviewed the instrument data and determined that it was consistent with the mixing issues.The hsc specialist stated, it is important that the samples are well mixed.Mixing by hand is uncontrolled and inefficient.Use of a rocker or a spiral mixer is the recommended procedure for mixing whole blood samples that are used for cell counts or for chemistry determinations.Based on the instrument data, the hsc specialist determined that the cause of the discordant, falsely elevated tacrolimus result on three patient samples was due to the sample related issue.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

Discordant, falsely elevated tacrolimus results were obtained on three patient samples on a dimension rxl max with hm instrument.The initial results were not reported to the physician(s).New samples were obtained from the patient and tested on a dimension exl located at another laboratory, resulting lower.The results from the dimension exl instrument were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tacrolimus results.

Manufacturer Narrative

The initial mdr 2517506-2018-00018 was filed on january 11, 2018.Additional information (01/23/2018): a siemens technical applications specialist (tas) guided the customer on how to properly work with the tacrolimus method, including running adequate sample volume, using a roller to mix samples instead of mixing by hand, using an automatic pipettor for aspiration of qc and patient samples, and processing sample tubes as soon as they are removed from the mixer.

• Brand Name: DIMENSION RXL MAX WITH HM
• Type of Device: DIMENSION® RXL MAX WITH HM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7182836
• MDR Text Key: 97756893
• Report Number: 2517506-2018-00018
• Device Sequence Number: 0
• Product Code: MLM
• Combination Product (y/n): N
• PMA/PMN Number: K112999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1