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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse replaced the source lamp and aligned it.The cause of the discordant tacrolimus results on four patient samples was related to a malfunction of the source lamp.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant tacrolimus results were obtained on four patient samples on a dimension rxl max with hm instrument.The discordant results were reported to the physician(s), who questioned them.The samples were repeated on the same instrument, resulting lower for samples (b)(6).The repeat results for samples (b)(6) were not provided by the customer.It is unknown which repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant tacrolimus results.

• Brand Name: DIMENSION RXL MAX WITH HM
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: michael metz ; 511 benedict ave; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 5079319
• MDR Text Key: 26642413
• Report Number: 1226181-2015-00524
• Device Sequence Number: 0
• Product Code: MLM
• 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
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• 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: 08/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2011
• 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