FDA Adverse Event
Injury
Summary report: N
D-TRONPLUS
MDR report key: 1003007
·
Received February 22, 2008
Report
- Report Number
- 2183996-2008-00202
- Event Type
- Injury
- Date Received
- February 22, 2008
- Date of Event
- January 25, 2008
- Report Date
- January 25, 2008
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- Product Code
- LZG
- PMA / PMN Number
- K043000
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PT REPORTED HE TRIED TO CHANGE THE BATTERY IN HIS INSULIN INFUSION DEVICE AND THE PISTON ROD STOPPED DURING RETRACTION. HE STATED HE COULD NOT GET THE PISTON ROD TO RESPOND EVEN AFTER CHANGING THE CARTRIDGE, ADAPTER, AND BATTERY, HE SAID HIS BLOOD GLUCOSE READING DURING THIS TIME WAS 545 MG/DL WITH HIS TARGET RANGE BEING 125 MG/DL. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | D-TRONPLUS | INSULIN INFUSION PUMP | LZG | DISETRONIC MEDICAL SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other| R | INSULIN INFUSION SET| INSULIN |