FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 2850625
·
Received November 16, 2012
Report
- Report Number
- 2183996-2012-01728
- Event Type
- Injury
- Date Received
- November 16, 2012
- Date of Event
- May 1, 2012
- Report Date
- October 31, 2012
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- LZG
- PMA / PMN Number
- K060876
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IS RELATED TO MEDWATCH: 2183996-2012-01729.
Description of Event or Problem · 1
ON (B)64) 2012, THE PATIENT REPORTED THAT IN (B)(6) 2012 SHE WENT TO THE HOSPITAL WITH A BLOOD GLUCOSE LEVEL OF 470 MG/DL AND WAS IN THE HOSPITAL FOR TWO WEEKS. THE PATIENT WAS GIVEN AN IV OF INSULIN AND THEN INJECTIONS OF INSULIN. HER NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. THE INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT | LZG | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Hospitalization| R | INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP |