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

Model Number IMMULITE 2000

Device Problem High Test Results (2457)

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

Event Date 01/25/2015

Event Type  malfunction  

Event Description

Discordant sex hormone-binding globulin (shbg) and insulin-like growth factors 1 (igf-1) results were obtained on patient samples on an immulite 2000 instrument.The results were obtained while quality controls (qc) were out of range.The discordant results were reported to the physician(s).The samples were not repeated by the customer.It is unknown if the samples were repeated at any other laboratory.There are no known reports of patient intervention or adverse health consequences due to the discordant shbg and igf-1 results.

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.Siemens investigation revealed that the customer had not been performing proper instrument maintenance.A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse discovered that the probe wash was not added to the system and that there were hairline cracks in the straws of both the probe wash bottles.The cse performed the instrument maintenance and replaced the probe wash bottles.The cse adjusted and ran quality controls, which were within the acceptable ranges.The cause of the discordant shbg and igf-1 results on patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 2247117-2015-000033 was filed on may 22, 2015.Additional/corrected information (05/22/2015): a siemens customer care center (ccc) specialist contacted the customer.The customer stated that they did not run any patient samples while the quality controls were out of range.Therefore, no discordant patient results were obtained.

• 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: michael metz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 4793040
• MDR Text Key: 5817715
• Report Number: 2247117-2015-00033
• Device Sequence Number: 1
• Product Code: CDZ
• 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: 01/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

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