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

Model Number DIMENSION RXL MAX WITH HM

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

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

Event Date 06/18/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) and technical application specialist (tas) were dispatched to the customer site to determine the cause of the discordant creatinine result on the dimension rxl max system and did not identify any problems.The cause of the discordant creatinine result is unknown.On june 19, 2017, maintenance was performed on the system and the aliquots wheels were replaced.The customer stated that no further discordant results were obtained on the affected dimension rxl max system.The instrument is performing according to specifications.No further evaluation of this device is required.Mdr 2517506-2017-00588 was filed for the same event.

Event Description

After a power failure that resulted in a shutdown of all lab equipment, a discordant, falsely depressed creatinine (creat) result was obtained on a patient sample on the dimension rxl max system.The discordant result was reported to the physician and the physician did not question the result.The same patient sample was repeated on an alternate dimension rxl max system with the same software version.The result obtained was different from the initial result reported to the physician.The corrected result was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed creatinine (creat) result.

Manufacturer Narrative

The initial mdr 2517506-2017-00587 was filed on july 13, 2017.Corrected information (july 18, 2017): the initial mdr stated that the corrected result was reported to the physician.Has been updated to correct the initial information.Additional information (july 18, 2017): the customer indicated that there were potentially other results that were reported with errors.However, the customer did not provide additional patient data.Supplemental mdr 2517506-2017-00588-s1 was filed for the same event.

Event Description

It is unknown whether the corrected result was provided to the physician.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6712161
• MDR Text Key: 80047879
• Report Number: 2517506-2017-00587
• Device Sequence Number: 0
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION RXL MAX WITH HM
• Device Catalogue Number: 10444829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2012
• 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