FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT CARTRIDGE
MDR report key: 2011806
·
Received February 9, 2011
Report
- Report Number
- 2183996-2011-00178
- Event Type
- Malfunction
- Date Received
- February 9, 2011
- Date of Event
- January 22, 2011
- Report Date
- January 24, 2011
- 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 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. NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE PATIENT REPORTED THE INSULIN CARTRIDGE LEAKS INSULIN. THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE (VALUE NOT PROVIDED). NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR OTHER PARTY TO ADDRESS THE ISSUE. THE INSULIN CARTRIDGE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN INFUSION SET| INSULIN| INSULIN INFUSION PUMP |