FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK D-TRONPLUS
MDR report key: 1420601
·
Received July 21, 2009
Report
- Report Number
- 2183996-2009-01496
- Event Type
- Injury
- Date Received
- July 21, 2009
- Date of Event
- June 23, 2009
- Report Date
- July 7, 2009
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE PATIENT'S VENDOR REPORTED THAT THE PATIENT HAS EXPERIENCED FREQUENT E4 (OCCLUSION) ERRORS FOR THE PAST 2 WEEKS WITH ELEVATED BLOOD GLUCOSE OF 14-19 MMOL/L (252-342 MG/DL). THE PATIENT CHANGED THE INFUSION SET AFTER 12 HOURS OF USE AND BOLUSED THROUGH THE INFUSION DEVICE TO LOWER HIS BLOOD GLUCOSE. NO FURTHER INFORMATION IS AVAILABLE. 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 | ACCU-CHEK D-TRONPLUS | INSULIN INFUSION PUMP | LZG | DISETRONIC MEDICAL SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INSULIN| INSULIN INFUSION SET |