ACCU-CHEK SPIRIT
Report
- Report Number
- 2183996-2008-00201
- Event Type
- Injury
- Date Received
- February 22, 2008
- Date of Event
- February 6, 2008
- Report Date
- February 8, 2008
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- Product Code
- LZG
- PMA / PMN Number
- K060876
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
NO PRODUCT WILL BE RETURNED FOR EVALUATION.
IN 2008, THE PT STATED THAT HER BLOOD GLUCOSE BEGAN TO ELEVATE ON THE SAME DAY. SHE STATED THAT SHE HAD A STOMACH VIRUS THAT MORNING AND WAS VOMITING AND SHE WAS ADMITTED TO THE HOSPITAL WITH A BLOOD GLUCOSE LEVEL OF 400-500 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. HER BLOOD GLUCOSE WAS MEASURED AT 592 MG/DL WHILE IN THE HOSPITAL AND SHE WAS GIVEN A 25 UNIT INJECTION OF INSULIN AND HER BLOOD GLUCOSE LOWERED TO 444 MG/DL. SHE STATED THAT TYPICALLY THAT AMOUNT OF INSULIN WOULD CAUSE HER BLOOD GLUCOSE TO BE LOW. SHE STATED THAT SHE HAS A VERY SLOW ABSORPTION RATE THAT MAY BE DUE TO SCARRING. SHE STATED THAT EARLIER IN THE DAY, HER BLOOD GLUCOSE HAD DECREASED TO 160 MG/DL. HER BLOOD GLUCOSE AT THE TIME OF THE REPORT MEASURED 368 MG/DL. HER PHYSICIAN REQUESTED THAT SHE RAISE HER BASAL RATES. TROUBLESHOOTING DID NOT REVEAL ANY PRODUCT ISSUES. UPON FOLLOW UP ON TWO DAYS LATER, THE PATIENT STATED SHE WAS RELEASED FROM THE HOSPITAL AND HER BLOOD GLUCOSE WAS "FINE". NO PRODUCT WILL 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 | YR | Hospitalization| O| R | INSULIN| INSULIN INFUSION SET |