FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 1953451
·
Received December 30, 2010
Report
- Report Number
- 2183996-2010-02700
- Event Type
- Injury
- Date Received
- December 30, 2010
- Date of Event
- December 20, 2010
- Report Date
- December 21, 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. 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
PT REPORTED THE INFUSION DEVICE SWITCHED OFF WITH AN ERROR MESSAGE. PT STATED THE INCIDENT OCCURRED AT NIGHT. PT REPORTED WAKING UP WITH AN ELEVATED BLOOD GLUCOSE LEVEL. PT'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PT'S NORMAL BLOOD GLUCOSE RANGE WAS NOT PROVIDED. TREATMENT RECEIVED WAS NOT PROVIDED. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE INSULIN DELIVERY SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | INSULIN| INSULIN INFUSION SET |