FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK D-TRONPLUS
MDR report key: 1964588
·
Received December 22, 2010
Report
- Report Number
- 2183996-2010-02659
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- September 10, 2010
- Report Date
- December 10, 2010
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT OCCURRED OUTSIDE THE U.S. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE PT REPORTED EXPERIENCING ERRATIC BLOOD GLUCOSE LEVELS OF 40-426 MG/DL FOR 3 MONTHS. HE BOLUSED THROUGH THE INFUSION DEVICE TO LOWER ELEVATED BLOOD GLUCOSE. HE ALSO REPORTED THE UP, DOWN, AND MENU BUTTONS ARE DAMAGED. HIS NORMAL BLOOD GLUCOSE LEVEL IS 130 MG/DL. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK D-TRONPLUS | INSULIN INFUSION PUMP | LZG | ROCHE INSULIN DELIVERY SYSTEMS INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | INSULIN| INSULIN INFUSION SET |