MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE

Model Number IMMULITE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care specialist (ccc).The ccc offered service to check the instrument, but the customer declined as they did not have an active contract on the system.The ccc remotely confirmed that all instrument maintenance was current and that no mechanical errors were posted on the event log at the time of testing.The ccc checked the adjustment data that was used to generate the < 5 iu/ml result, as well as the quality control results from the system.The adjustment parameters and the quality control results were within range.The cause of the discordant, false negative rubella igg result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, false negative rubella igg result was obtained on one patient sample on an immulite instrument.It is unknown if the initial result was reported to the physician(s).Five days later, the initial sample was tested in duplicate on the same instrument and same reagent lot, resulting positive.The patient was then re-drawn a few days later and this re-draw sample resulted positive.The re-draw sample was also sent to a reference laboratory where it resulted positive as well.It is unknown if the repeat results were reported to the physician(s).There are no known reports of patient intervention due to the false negative rubella igg result.There are no known reports of a delay in administering treatment or medical intervention to the patient due to the false negative rubella igg result.

Manufacturer Narrative

The initial mdr 2247117-2017-00025 was filed on february 27, 2017.Additional information (03/07/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer and stated that the adjustment and control data were normal.The cause of the event could not be determined, but the customer may have accidentally tested the wrong sample initially.Based on the available information, immulite rubella quantitative igg lot 0336 is performing as intended.The cause of the discordant, false negative rubella igg result is unknown.No further evaluation of the device is required.

• Brand Name: IMMULITE
• Type of Device: IMMULITE
• 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: devyani chaudhuri ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242637
• MDR Report Key: 6360715
• MDR Text Key: 68418454
• Report Number: 2247117-2017-00025
• Device Sequence Number: 0
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• 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