FDA Adverse Event
Other
Summary report: N
MEDI-JECTOR CHOICE
MDR report key: 276648
·
Received May 5, 2000
Report
- Report Number
- 2182861-2000-00004
- Event Type
- Other
- Date Received
- May 5, 2000
- Date of Event
- April 24, 2000
- Report Date
- May 4, 2000
- Manufacturer
- MEDI-JECT CORP.
- Product Code
- KZE
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PT EXPERIENCED "WET" INJECTIONS ON 04/24/2000. AT THE TIME OF INJECTION, BLOOD GLUCOSE WAS OVER 400. THE NEXT MORNING PT'S BLOOD GLUCOSE LEVEL WAS OVER 550. PT WAS FEELING ILL AND VOMITING. PT WAS ADMITTED TO THE HOSP FOR TWO DAYS TO ESTABLISH PT'S BLOOD SUGAR. PT SUBSEQUENTLY USED THE DEVICE ON THE 25TH AND 26TH WITH NO PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDI-JECTOR CHOICE | NEEDLE-FREE INJECTOR | KZE | MEDI-JECT CORP. | 300036-001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization |