MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 1000

Model Number IMMULITE 1000

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2014

Event Type  malfunction  

Event Description

The customer reported a delay in obtaining a result for one patient tested for intra-operative parathyroid hormone (ipth) on an immulite 1000 instrument.The patient was delayed for two hours in recovery.There are no known reports of patient intervention or adverse health consequences due to the delayed ipth result.

Manufacturer Narrative

A siemens field service engineer (fse) was dispatched to the customer's site.The fse evaluated the instrument and observed that the bulb on substrate module was damaged which prevented substrate from being primed through the lines.The fse repaired the bulb and the customer ran a decontamination.A water test was run to verify that there was no contamination in the instrument.The water test values were within acceptable ranges.After servicing, the customer ran the quality controls which were in range.During follow-up with the customer, the customer indicated that patient samples were running as expected.The cause of the delayed ipth result was due to a malfunction of the bulb on the substrate module.The instrument is performing according to the specifications.No further evaluation of this device is required.

• Brand Name: IMMULITE 1000
• Type of Device: IMMULITE 1000
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders NJ 07836
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4221507
• MDR Text Key: 4997454
• Report Number: 2247117-2014-00066
• Device Sequence Number: 1
• Product Code: CEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 1000
• Device Catalogue Number: 30006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: No
• 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