MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

Model Number IMMULITE 2000

Device Problem False Positive Result (1227)

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

Event Date 04/17/2015

Event Type  malfunction  

Event Description

Discordant, false positive h.Pylori igg results were obtained on two patient samples on an immulite 2000 instrument.The discordant results were reported to the physician(s).The samples were repeated on an alternate immulite 2000 instrument, resulting negative.The corrected results were not reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, false positive h.Pylori results.

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer stated that they received probe wash errors while running the patient samples.A siemens headquarters support center (hsc) specialist reviewed the instrument data and stated that the discordant results were consistent with the instrument running out of water.A siemens customer service engineer (cse) was dispatched to the customer site.The cse evaluated the instrument and tested the washing, the pipetting and the reading mechanisms.The cse could not find any instrument malfunction.The cse ran quality controls, which were within the acceptable ranges.The cause of the discordant, false positive h.Pylori igg results on two patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: IMMULITE 2000
• Type of Device: IMMULITE 2000
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; 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: 4775329
• MDR Text Key: 18030724
• Report Number: 2247117-2015-00028
• Device Sequence Number: 1
• Product Code: LYR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K970227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• 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: 04/22/2015
• 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