ACCU-CHEK SPIRIT
Report
- Report Number
- 2183996-2011-00096
- Event Type
- Injury
- Date Received
- January 31, 2011
- Date of Event
- January 9, 2011
- Report Date
- January 11, 2011
- 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 Occupation
- UNKNOWN
Narratives
NO PRODUCT WILL BE RETURNED FOR EVALUATION.
ON (B)(6) 2011, PT REPORTED SHE NEEDS TO LOWER THE BASAL RATE ON HER INFUSION DEVICE BECAUSE SHE HAD A SEVERE LOW BLOOD GLUCOSE LEVEL REQUIRING HOSPITALIZATION. PT STATED ON (B)(6) 2011, SHE WAS SLEEPING AND HER HUSBAND HEARD HER WHIMPERING. PT REPORTED HER HUSBAND WOKE UP AND FOUND HER UNRESPONSIVE AND THEN SHE WENT INTO A SEIZURE. PT STATED HER BLOOD GLUCOSE LEVEL WAS UNK BECAUSE SHE WAS UNCONSCIOUS. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 4-9 MMOL/L (72-162 MG/DL). PT STATED HER HUSBAND CALLED THE PARAMEDICS IMMEDIATELY. PT REPORTED SHE WAS GIVEN A GLUCOSE INJECTION BY THE PARAMEDICS AND TRANSPORTED TO THE HOSPITAL. PT STATED SHE WAS AT THE HOSPITAL FOR ABOUT 8 HOURS AND THEY RAN VARIOUS TESTS AND TOOK X-RAYS. PT REPORTED THE HOSPITAL DETERMINED THE SEIZURE WAS DUE TO EXTREMELY LOW BLOOD GLUCOSE AND SHE WAS RELEASED THE SAME DAY. PT STATED SHE HAS BEEN HAVING FREQUENT LOW BLOOD GLUCOSE BUT HAS BEEN ABLE TO SELF TREAT WITH JUICE EACH TIME. PT REPORTED SHE IS GOING TO KEEP WORKING WITH HER DOCTOR TO SEE HOW THIS CONCERN CAN BEST BE ADDRESSED. TROUBLESHOOTING DID NOT FIND ANY PRODUCT ISSUES. NO PRODUCT RETURN WAS REQUESTED.
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 | 31 YR | Hospitalization| O| R | INSULIN INFUSION SET| INSULIN |