FDA Adverse Event
Malfunction
Summary report: N
D-TRONPLUS
MDR report key: 5303289
·
Received September 17, 2004
Report
- Report Number
- 2183996-2004-00677
- Event Type
- Malfunction
- Date Received
- September 17, 2004
- Date of Event
- August 24, 2004
- Report Date
- August 24, 2004
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS, INC.
- Product Code
- L Z
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
PT REPORTED THAT SHE EXPERIENCED HIGH BLOOD GLUCOSE (336 MG/DL). PT'S BLOOD GLUCOSE HAS BEEN ELEVATED FOR THREE WEEKS. NO ERROR MESSAGES WERE GENERATED BY THE DEVICE. PT ALLEGED THAT DEVICE WAS AT FAULT FOR HIGH BLOOD GLUCOSE. NO TREATMENT WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | D-TRONPLUS | INSULIN INFUSION PUMP | L Z | DISETRONIC MEDICAL SYSTEMS, INC. | D-TRONPLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |