MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 TIMOTHY GRASS; ALLERGEN SPECIFIC IGE

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	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of a depressed result with specific ige on immulite 2000 for timothy grass (lot 624) compared to a higher result observed with timothy grass (lot 625).The depressed result was reported to the physician(s), who did not question the result.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed allergen specific ige result.
Additional Manufacturer Narrative
The customer reports observation of a depressed result with specific ige on immulite 2000 for timothy grass (lot 624) compared to a higher result observed with timothy grass (lot 625).The depressed result was reported to the physician(s), who did not question the result.The limitations section of the immulite 2000 allergen specific ige instructions for use (ifu) states: "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." siemens healthcare diagnostics is investigating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00063 on mar 28, 2023.Additional information may 19, 2023: the customer reports observation of a depressed result with specific ige on immulite 2000 for timothy grass (lot 624) compared to a higher result observed with timothy grass (lot 625).The depressed result was reported to the physician(s), who did not question the result.Siemens reviewed the diagnostic files for a discrepant result for immulite 2000 3gallergy specific ige g6 sample.The discrepant sample was run with g6 allergen lot 624 which resulted as 1.21 iu/ml on february 16, 2023.The sample was repeated with lot 625 on (b)(6) 2023 which gave a result of 22.5 iu/ml and subsequently repeated on (b)(6) 2023 with a result of 23.5 iu/ml.A review of the diagnostic files show a potential bubble in the reagent that may have caused the discrepant result.The customer is operational.In section b6 of initial mdr: it was stated that the patient sample (b)(6) was repeated with a result of 22.5 iu/ml (lot 625) on (b)(6) 2023.The correct test date is (b)(6) 2023.The follwing data was not reviewed by siemens from the diagnostic files - lot 625 repeat result: 24.2 iu/ml.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: IMMULITE 2000 TIMOTHY GRASS
• Common Device Name: ALLERGEN SPECIFIC IGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis,; gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; uk registration #: 3002806944; glyn rhonwy; llanberis, gwynedd LL55 4EL; UK LL55 4EL
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16628545
• Report Number: 1219913-2023-00063
• Device Sequence Number: 5269197
• Product Code: DHB
• UDI-Device Identifier: 00630414960579
• UDI-Public: 00630414960579
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K013134
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 10385924
• Device Lot Number: 624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown