FDA Adverse Event
Injury
Summary report: N
H-TRONPLUS
MDR report key: 1082216
·
Received July 25, 2008
Report
- Report Number
- 2183996-2008-01096
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- December 15, 2007
- Report Date
- July 15, 2008
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- Product Code
- LZG
- PMA / PMN Number
- K023471
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IN 2008, THE PATIENT REPORTED THAT HE HAS EXPERIENCED ELEVATED BLOOD GLUCOSE FOR THE PAST 7 MONTHS. HE WAS UNABLE TO PROVIDE SPECIFIC VALUES BUT STATED THAT HIS HBA1C IS OVER 9. HE STATED THAT HE IS HAVING TROUBLE USING THE INFUSION DEVICE TO KEEP HIS BLOOD GLUCOSE UNDER CONTROL AND HE "NEEDS MORE AND MORE INSULIN." HE ADJUSTS HIS BASAL RATES AND BOLUS AMOUNTS BUT CONTINUES TO EXPERIENCE ELEVATED READINGS. HE IS UNSURE OF THE CAUSE OF ELEVATED BLOOD GLUCOSE, BUT BELIEVES, IT COULD BE DUE TO THE INFUSION DEVICE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | H-TRONPLUS | INSULIN INFUSION PUMP | LZG | DISETRONIC MEDICAL SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INSULIN INFUSION SET| INSULIN |