DIMENSION? RXL MAX WITH HM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-01-11 for DIMENSION? RXL MAX WITH HM manufactured by Siemens Healthcare Diagnostics Inc.

Event Text Entries

[97756893] 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.
Patient Sequence No: 1, Text Type: N, H10

[97756894] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2517506-2018-00018
• MDR Report Key: 7182836
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2018-01-11
• Date of Report: 2018-02-05
• Date of Event: 2017-12-15
• Date Mfgr Received: 2018-01-23
• Device Manufacturer Date: 2009-02-26
• Date Added to Maude: 2018-01-11
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: CASSANDRA KOCSIS
• Manufacturer Street: 511 BENEDICT AVE
• Manufacturer City: TARRYTOWN NY 10591
• Manufacturer Country: US
• Manufacturer Postal: 10591
• Manufacturer Phone: 9145242687
• Manufacturer G1: SIEMENS HEALTHCARE DIAGNOSTICS INC.
• Manufacturer Street: 101 SILVERMINE ROAD REGISTRATION #:1226181
• Manufacturer City: BROOKFIELD CT 06804
• Manufacturer Country: US
• Manufacturer Postal Code: 06804
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: DIMENSION? RXL MAX WITH HM
• Generic Name: DIMENSION? RXL MAX WITH HM
• Product Code: MLM
• Date Received: 2018-01-11
• Model Number: DIMENSION? RXL MAX WITH HM
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC
• Manufacturer Address: 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101

Device Sequence Number: 1

• Brand Name: DIMENSION? RXL MAX WITH HM
• Generic Name: DIMENSION? RXL MAX WITH HM
• Product Code: JJE
• Date Received: 2018-01-11
• Model Number: DIMENSION? RXL MAX WITH HM
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC
• Manufacturer Address: 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-01-11