FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK SPIRIT CARTRIDGE
MDR report key: 1872030
·
Received October 8, 2010
Report
- Report Number
- 2183996-2010-02092
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- September 29, 2010
- Report Date
- October 3, 2010
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- 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 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
PATIENT REPORTED INSULIN CARTRIDGE WAS LEAKY AND THIS RESULTED IN HYPERGLYCEMIA OF 460 MG/DL. PATIENT CORRECTED ELEVATED BLOOD GLUCOSE BY INFUSION DEVICE. PATIENT CHANGES INFUSION HEADSET EVERY DAY AND INFUSION TUBING EVERY 2.5 DAYS. TARGET BLOOD GLUCOSE IS 120-180 MG/DL. INSULIN CARTRIDGE WAS REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT CARTRIDGE | INSULIN INFUSION PUMP CARTRIDGE | LZG | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | 32143360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention | INFUSION DEVICE| INSULIN INFUSION SET| INSULIN |