FDA Adverse Event
Injury
Summary report: N
QUANTIFERON®-TB GOLD PLUS
MDR report key: 18817510
·
Received February 29, 2024
Report
- Report Number
- MW5152238
- Event Type
- Injury
- Date Received
- February 29, 2024
- Date of Event
- September 20, 2020
- Report Date
- February 13, 2024
- Manufacturer
- QIAGEN
- Product Code
- NCD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
(B)(6) MISDIAGNOSED ME. THE CLINIC EVENTUALLY MADE ME GO UNDER TREATMENT OF ANTIBIOTICS MY BODY DIDN'T NEED. NOW, MY BODY IS ANTIBIOTIC RESISTANT AND I'M SUFFERING FROM MULTIPLE STOMACH INFECTIONS. TUBERCULOSIS SCREEN, POSITIVE PPD/ IGRA. MY CURRENT MEDICAL PROVIDER AT THE (B)(6) UPDATED MY FILE TO REFLECT I'M NEGATIVE TESTER BUT CAN'T UNDO THE FACT THAT I WAS TREATED WITH ANTIBIOTICS MY BODY DIDN'T NEED. MAKING IT AN OVERUSE OF ANTIBIOTICS. MY BODY HAS BECOME ANTIBIOTIC RESISTANT AND I UNABLE TO FIGHT OFF STOMACH INFECTIONS. I HAD A BABY (B)(6) 2019 AND MY BABY HAS MULTIPLE DISABILITIES. LTBI (LATENT TUBERCULOSIS INFECTION) TESTED: (B)(6) 2018, 12 DOSES OF LTBI 3HP MY BODY CLEARLY DIDN'T NEED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 696349 | QUANTIFERON®-TB GOLD PLUS | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS | NCD | QIAGEN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Congenital Anomaly| O| S |