FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 1012660
·
Received March 11, 2008
Report
- Report Number
- 2183996-2008-00322
- Event Type
- Injury
- Date Received
- March 11, 2008
- Date of Event
- March 3, 2008
- Report Date
- March 10, 2008
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- 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
Description of Event or Problem · 1
IN 2008, THE PT WAS FOUND UNCONSCIOUS BY A CO-WORKER AND WAS TAKEN BY AMBULANCE TO THE HOSPITAL. SHE WAS DISCONNECTED FROM HER INFUSION DEVICE. HER BLOOD GLUCOSE MEASURED 35 MG/DL. SHE BECAME RESPONSIVE ON THE FOLLOWING DAY. SHE WAS IN THE INTENSIVE CARE UNIT FOR FOUR DAYS AND WAS THEN MOVED TO ANOTHER UNIT OF THE HOSPITAL. NO FURTHER INFO IS AVAILABLE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT | INSULIN INFUSION PUMP | LZG | DISETRONIC MEDICAL SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| R | INSULIN| INSULIN INFUSION SET |