FDA Adverse Event
Injury
Summary report: N
D-TRONPLUS CARTRIDGE
MDR report key: 1063331
·
Received June 19, 2008
Report
- Report Number
- 2183996-2008-00885
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 7, 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
- ME, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON 06/07/2008, THE PT REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 400 MG/DL ON THE DAY BEFORE. HE STATED HIS SYMPTOMS WERE CRAMPS, NAUSEA, AND TENSE MUSCLES AND HE CORRECTED HIS READING BY BOLUSING INSULIN THROUGH HIS INSULIN INFUSION DEVICE. ON TWO DAYS AFTER THE ORIGINAL DATE, THE PT CALLED BACK AND SAID, HE DISCOVERED THE GLASS INSULIN CARTRIDGE IN THE DEVICE WAS CRACKED AND INSULIN WAS LEAKING OUT INSIDE THE DEVICE. HE SAID HE BELIEVES THIS IS THE REASON FOR THE ELEVATED READING. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | D-TRONPLUS CARTRIDGE | INSULIN INFUSION PUMP CARTRIDGE | LZG | DISETRONIC MEDICAL SYSTEMS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INSULIN INFUSION SET| INSULIN| INSULIN INFUSION PUMP |