FDA Adverse Event
Malfunction
Summary report: N
ID CORE XT
MDR report key: 23189910
·
Received October 1, 2025
Report
- Report Number
- 3006413195-2025-00019
- Event Type
- Malfunction
- Date Received
- October 1, 2025
- Date of Event
- April 22, 2025
- Report Date
- October 1, 2025
- Manufacturer
- PROGENIKA BIOPHARMA, S.A
- Product Code
- PEP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE SAMPLE (B)(6), FROM "(B)(6)", WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS NEGATIVE (LUB-), WHICH CONTRASTED WITH MOLECULAR TYPING PERFORMED ON (B)(6) 2025, USING THE ID CORE XT ASSAY WHICH PROVIDED A POSITIVE RESULT (LUB+) WITH ID CORE XT ANALYSIS SOFTWARE V3.0.2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1795416 | ID CORE XT | ANTIGEN GENOTYPING TEST | PEP | PROGENIKA BIOPHARMA, S.A | 0203000038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |