MAUDE Adverse Event Report: SIEMENS HEALTCHCARE DIAGNOSTICS INC IMMULITE 2000

Model Number IMMULITE 2000

Device Problem Low Test Results (2458)

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

Event Date 05/18/2015

Event Type  malfunction  

Event Description

A discordant, falsely low alpha-fetoprotein (afp) result was obtained on one patient sample on an immulite 2000 instrument.The discordant result was reported to the physician(s), who questioned it.The sample was repeated on an alternate immulite instrument, resulting higher.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low afp result.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse did not find an instrument malfunction.The cause of the discordant, falsely low afp result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 2247117-2015-00036 was filed on june 12, 2015.(b)(4).

• Brand Name: IMMULITE 2000
• Type of Device: IMMULITE 2000
• Manufacturer (Section D): SIEMENS HEALTCHCARE DIAGNOSTICS INC; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 4841753
• MDR Text Key: 5871467
• Report Number: 2247117-2015-00036
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970227
• 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,Followup
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000
• Device Catalogue Number: 30002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2015
• 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