FDA Adverse Event
Malfunction
Summary report: N
H-TRONPLUS
MDR report key: 556718
·
Received April 30, 2004
Report
- Report Number
- 2183996-2004-00249
- Event Type
- Malfunction
- Date Received
- April 30, 2004
- Date of Event
- February 29, 2004
- Report Date
- April 12, 2004
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS, INC.
- Product Code
- LZG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
PT REPORTED THAT SINCE THE END OF THE MONTH THE BATTERIES FOR THEIR DEVICE HAVE ONLY LASTED 10 DAYS. PT ALSO REPORTED THAT DEVICE IS NOISY ALL OF THE TIME. PT HAS BEEN EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS (220-270 MG/DL) SINCE 2 MOS BEFORE. PT SELF-TREATED HIGH BLOOD GLUCOSE BY INCREASING THEIR BOLUS AMOUNT BY APPROXIMATELY 20%.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | H-TRONPLUS | INSULIN INFUSION PUMP | LZG | DISETRONIC MEDICAL SYSTEMS, INC. | H-TRONPLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | INSULIN INFUSION SET, DATE OF TREATMENT: NA| INSULIN |