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

Model Number IMMULITE 2000 XPI

Device Problem Insufficient Information (3190)

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

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the falsely low result on the immulite 2000 xpi is unknown.Siemens healthcare is investigating the issue.

Event Description

The customer has obtained a falsely low result on a patient sample for the estradiol assay on an immulite 2000 xpi.The initial result was not reported to the physician(s) as it did not fit the clinical picture of the patient.The patient was redrawn and the sample was tested neat, and at a 1:5 dilution and the values were within expectations.The customer then repeated the original sample that gave the falsely low result and the result obtained upon repeat was acceptable to the customer.It is unknown if the repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely low result obtained on the immulite 2000 xpi.

Manufacturer Narrative

Initial mdr 2247117-2016-00007 was filed on 2/9/2016.Correction: pid# of initial mdr for the initial low result ((b)(6) 2016) was incorrectly listed as (b)(4).The correct pid# is (b)(4).The pid# for the redraw on (b)(6) 2016 is (b)(4).Additional information (02/22/2016): please note information on new patient sample.Siemens healthcare has contacted the customer site and requested that the samples be shipped to siemens for in-house testing.The instrument files have also been received by siemens headquarters support center (hsc) for review.On 2/25/2016 siemens hsc reviewed the instrument files provided by the customer for the initial discordant result reported in mdr 2247117-2016-0007.There was nothing observed in the instrument files that indicated a malfunction in the instrument while the sample was running.The cause of the initial discordant is unknown.Siemens healthcare is investigating the issue.

Event Description

A second falsely low result was obtained on a patient sample for the estradiol assay on an immulite 2000 xpi.The patient sample was run neat and at a 1:5 dilution.The neat result was lower than the result obtained on the 1:5 dilution.The sample was repeated again neat and at a 1:5 dilution, and the results obtained were acceptable to the customer.It is unknown if the initial and repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely low result obtained on the immulite 2000 xpi.

Manufacturer Narrative

Initial mdr 2247117-2016-00007 was filed on 2/9/2016.Follow up mdr 2247117-2016-00007_s1 was filed on 3/14/2016.Follow up mdr 2247117-2016-00007_s2 was filed on 3/16/2016.Additional information (3/16/2016): siemens headquarters support center (hsc) reviewed the instrument files provided by the customer for the additional two discordant results for the estradiol assay provided in mdr follow up 2247117-2016-00007_s1.Quality control samples and adjustments for the assay were within specifications when the samples were run.There were no errors and nothing observed in the instrument files that indicated a malfunction with the instrument while the samples were being processed.Samples were received by siemens from the customer site but were incorrectly shipped at room temperature instead of frozen as per the instructions for use (ifu).As the samples could be compromised in-house testing cannot be carried out, and further investigation has been cancelled.The cause of the additional two discordants is unknown.

• Brand Name: IMMULITE 2000 XPI
• Type of Device: IMMULITE 2000 XPI
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders NY 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 62 flanders bartley road; p.o. box 6101; flanders NJ 07836 6101
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 5418573
• MDR Text Key: 37741609
• Report Number: 2247117-2016-00007
• Device Sequence Number: 1
• Product Code: JJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010053/S007
• 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,Followup,Followup
• Report Date: 01/15/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IMMULITE 2000 XPI
• Device Catalogue Number: 030001-3
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1