MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 FOOD PANEL 5

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics is investigating this event.The limitations section of the instructions for use states the following: "a definitive clinical diagnosis should not be made solely on the basis of an in vitro allergen-specific ige result.Diagnosis should be made by the physician only after all clinical and laboratory findings have been evaluated.".
Event or Problem Description
The customer observed a negative (class 0) result using the immulite 2000 food panel 5 assay, reagent lot 620, which was discordant relative to a positive (class 1) repeat-testing result obtained using reagent lot 621 of the same product.There are no known reports of patient intervention or adverse health consequences due to the discordant result.
Additional Manufacturer Narrative
Mdr was submitted on 2021-02-08 to report a negative result from the immulite 2000 food panel 5 assay which was discordant relative to repeat testing using a different reagent lot.Siemens healthcare diagnostics has concluded the incident investigation.Customer data were reviewed.Following the observation of result disagreement, the customer began to run individual-allergen tests in addition to the food panel assay, and comparing panel-result indications to individual-allergen component results.The customer noted some cases of disagreement between these test methods.Further investigation revealed that the customer was applying an inappropriate ku/l threshold for distinguishing reactive (positive) from nonreactive (negative) results.The assay instructions for use defines the range from 0.1 to 0.34 ku/l as "very low", where the customer had interpreted these results as negative.Following this clarification, there were still some observations which demonstrated inconsistency between panel and individual-allergen results.Samples were requested for testing, but were not available.Product stability data for the food panel 5 assay were reviewed, and although some decrease in measurements was observed for this assay over time, results did not change from positive to negative; no product issue was indicated.No manufacturing issues or product problems were identified.The system is working within specifications, no further support is requested by the customer, and no further action is required.Note: coding for investigation findings and investigation conclusions has been updated in section h6.

• Brand Name: IMMULITE 2000 FOOD PANEL 5
• Common Device Name: IMMULITE 2000 FOOD PANEL 5
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; gwynedd, LL55 4EL; UK LL55 4EL
• MDR Report Key: 11296405
• Report Number: 1219913-2021-00091
• Device Sequence Number: 17351224
• Product Code: DHB
• UDI-Device Identifier: 00630414960432
• UDI-Public: 00630414960432
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K013135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 10385897
• Device Lot Number: 620
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1