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 05/28/2015

Event Type  malfunction  

Event Description

Discordant alpha fetoprotein (afp), antithyroid peroxidase antibodies (ata), dehydroepiandrosterone sulfate (dhea-so4), homocysteine (hcy), helicobater pylori igg (hpg), cancer antigen marker (ca-125), sex hormone-binding globulin (shbg), testosterone (tes), thyroglobulin (tg) and the customer's calculated free testosterone (tesfc) results were obtained on multiple patient samples on an immulite 2000 instrument.The discordant results were reported to the physician(s).After troubleshooting, the samples were repeated on the same instrument, resulting different from the initial results.The corrected results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant afp, ata, dhea-so4, hcy, hpg, shbg, ca-125, tes, tg and tesfc results.

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse discovered that the reagent dual resolution dilutor (drd) was broken.The cse replaced and adjusted the drd and the valves and ran the water test, which was acceptable.The customer ran quality controls, which were within acceptable ranges.The cause of the discordant afp, ata, dhea-so4, hcy, hpg, shbg, ca-125, tes, tg and tesfc results on multiple patient samples was related to the broken reagent drd.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 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: 4867922
• MDR Text Key: 20751097
• Report Number: 2247117-2015-00038
• Device Sequence Number: 1
• Product Code: DGC
• 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
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• 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: 06/01/2015
• 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