FDA Adverse Event
Injury
Summary report: N
D-TRONPLUS
MDR report key: 1071417
·
Received July 7, 2008
Report
- Report Number
- 2183996-2008-01005
- Event Type
- Injury
- Date Received
- July 7, 2008
- Date of Event
- June 4, 2008
- Report Date
- June 4, 2008
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- Product Code
- LZG
- PMA / PMN Number
- K022831
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IN 2008, THE PATIENT REPORTED THAT THE BASAL RATES ARE NOT FULLY DISPLAYED ON THE SCREEN OF HIS INFUSION DEVICE AND THE DISPLAY IS PARTIAL. HE STATED THAT HE EXPERIENCED LOW BLOOD GLUCOSE OF 40 MG/DL AS A RESULT AND HE DID NOT FEEL WELL. HIS NORMAL BLOOD GLUCOSE RANGE IS 80-130 MG/DL. HE ATE TO ELEVATE HIS READINGS. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.
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 | Required Intervention | INSULIN| INSULIN INFUSION SET |