MAUDE Adverse Event Report: PHADIA AB PHADIA 1000

Catalog Number	12-3800-01
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discrepancies were found with a patient's results for multiple immunocap allegen(s)/ allergen component(s).The sample was initially tested ((b)(6) 2025) on phadia 1000 instrument, serial number: (b)(6), yielding the following results: immunocap allergen f13, peanut: <0.10/ class 0.Immunocap allergen component rara h2 peanut f423: 0.09/ class 0.Immunocap allergen f23, crab: <0.10/ class 0.Immunocap allergen f202 cashew nut: <0.10/ class 0.Immunocap allergen f207, clam: <0.10/ class 0.Immunocap allergen f290, oyster: <0.10/ class 0.Immunocap allergen f338, scallop: <0.10/ class 0.The sample was repeated (10/01/2025) on alternate phadia 1000 instrument, serial no: (b)(6), the same immunocap allegen(s)/ allergen component(s) yielded the following results: immunocap allergen f13, peanut: >100/ class 6.Immunocap allergen component rara h2 peanut f423: >100/ class 6.Immunocap allergen f23, crab: 33.2/ class 4.Immunocap allergen f202, cashew nut: 21.1/ class 4.Immunocap allergen f207, clam: 13.6/ class 3.Immunocap allergen f290, oyster: 7.60/ class 3.Immunocap allergen f338, scallop: 20.9/ class 4.The repeat test results aligned more with the patient's history.Investigation is ongoing to determine possible root-cause.There is insufficient information if any adverse event has occured.
Event or Problem Description
Discrepancies were found with a patient's results for multiple immunocap allergen(s) / allergen component(s).The patient sample was tested on phadia 1000 instrument (serial number: (b)(6)) with immunocap allergen(s) / allergen component(s) yielding negative results.The sample was tested again on alternate phadia 1000 instrument (serial no: (b)(6)) with the same immunocap allergen(s) / allergen component(s) and yielded the positive results.The repeat test results aligned more with the patient's history.

• Brand Name: PHADIA 1000
• Common Device Name: PHADIA 1000
• Manufacturer (Section D): PHADIA AB; rapsgatan 7p; uppsala, uppsala 751 3 7; SW 751 37
• MDR Report Key: 23303653
• Report Number: 3004973408-2025-00002
• Device Sequence Number: 10192986
• Product Code: DHB
• UDI-Device Identifier: 07333066001005
• UDI-Public: (01)07333066001005(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/15/2025
• Report Date (Section F): 10/07/2025

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: Other
• Device Catalogue Number: 12-3800-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2025
• Device Age: 10 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown