MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-19 for HOLOGIC manufactured by Hologic.
[1667398]
Cytology department noticed several afb positive cases on bronchial brush specimens. The department questioned the validity of the questionable results and validated against pt cultures. Suspected a contaminant in the hologic thin-prep vial. This was verified by preparing a "blank" vial and it rendered an "afb positive" result. Dates of use: (b)(4) 2010. Diagnosis or reason for use: test to rule out tb. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017887 |
| MDR Report Key | 1881999 |
| Date Received | 2010-10-19 |
| Date of Report | 2010-10-19 |
| Date of Event | 2010-09-02 |
| Date Added to Maude | 2010-11-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLOGIC |
| Generic Name | THIN PREP VIAL |
| Product Code | LEA |
| Date Received | 2010-10-19 |
| Lot Number | 04068V |
| Device Expiration Date | 2012-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC |
| Manufacturer Address | FOXBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-19 |