MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD DIMENSION® CLINICAL CHEMISTRY SYSTEM; DIMENSION® RXL MAX CLINICAL CHEMISTRY SYSTEM WITH HM

Catalog Number 10444827

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that cause for the falsely depressed tpsa result is user error.A flagged result which is not reportable per operator's guide instructions was reported.The siemens healthcare diagnostics customer care center educated the customer on non-reportable flags.The customer confirmed that they resolved their situation by configuring their lis not to transmit non-reportable results.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

A discrepant depressed total prostate specific antigen (tpsa) result was obtained on a patient sample on the dimension system.The result was reported to the physician.The patient's subsequent sample was tested and an elevated was obtained and reported.The account stated that patient treatment (type not provided) was withheld on the basis of the discrepant depressed tpsa result.There was no report of adverse health consequences as a result of the discrepant depressed tpsa result or withheld treatment.

• Brand Name: DIMENSION® CLINICAL CHEMISTRY SYSTEM
• Type of Device: DIMENSION® RXL MAX CLINICAL CHEMISTRY SYSTEM WITH HM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5078113
• MDR Text Key: 26642265
• Report Number: 1226181-2015-00523
• Device Sequence Number: 0
• Product Code: LTJ
• 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: Medical Technologist
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Catalogue Number: 10444827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 89 YR