MAUDE Adverse Event Report: SIEMENS DPC IMMULITE 200 I2K; ANALYZER

Model Number IMMULITE 2000

Device Problem Inadequate Service (1564)

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

Event Date 09/12/2014

Event Type  malfunction  

Event Description

Siemens medical distributes reagents for the immulite 2000 hormone analyzer.Siemens purchased the immulite machine from dpc the original manufacturer whom we purchased from.When purchased, the dpc included online, continuous contact with dpc that would monitor performance of the machine.We have had an account with siemens for over 12 years with our immulite 2000.We order reagents to assure uninterrupted operation of the analyzer which is used to provide important, daily ongoing care to patients under our care.Since siemens assumed control of the company, the following problems have arisen and multiple complaints to siemens to rectify the problems have gone unheeded; the online monitoring of the machine is inactive.We were assured we would be contacted by siemens in the event of a machine malfunction.This does not occur as the online monitoring is non-functional even though this service is paid for; we are constantly having our reagent shipments placed "on hold" for accounting reasons in spite of a 14 year old history with dpc and then siemens of account maintenance.This unannounced placement of reagents on hold has been protested in the past as causing a major threat to patient care.Siemens disagrees.

• Brand Name: DPC IMMULITE 200 I2K
• Type of Device: ANALYZER
• Manufacturer (Section D): SIEMENS; malvern 19355
• MDR Report Key: 4098146
• MDR Text Key: 21971640
• Report Number: MW5038225
• Device Sequence Number: 1
• Product Code: JIL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Weight: 55