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

Model Number IMMULITE 2000

Device Problem Mechanical Problem (1384)

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

Event Date 08/30/2015

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist and reported that the sample valve to the left of the sample dual resolution dilutor (drd) was leaking.The customer tightened the fitting and performed priming.The customer requested that service be dispatched.A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse tightened the sample valve fittings and the issue resolved.The cse ran patient samples and the results correlated with the alternate immulite 2000 instrument.The customer did not obtain additional discordant results.The cause of the discordant estradiol results on three patient samples was related to the leak from the sample valve to the left of the sample drd.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant estradiol (e2) results were obtained on three patient samples when run in duplicate on an immulite 2000 instrument.The discordant results were reported to the physician(s).The samples were repeated on an alternate immulite 2000 instrument in duplicate, resulting different from the original results.The repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant estradiol results.

• Brand Name: IMMULITE 2000
• Type of Device: IMMULITE 2000
• 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: 5106140
• MDR Text Key: 26828212
• Report Number: 2247117-2015-00052
• Device Sequence Number: 0
• Product Code: CHP
• 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 faci
• Reporter Occupation: Health Professional
• Report Date: 08/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2015
• 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