FDA Adverse Event
Injury
Summary report: N
SPIRIT INSULIN PUMP
MDR report key: 17532368
·
Received August 12, 2023
Report
- Report Number
- MW5139276
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- September 16, 2010
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS AG
- Product Code
- LZG
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CUSTOMER HAD A READING OF 385 MG/DL AROUND 7 AM. THAT DAY. CUSTOMER SAID THIS WAS HIGH AND SHE TOOK 6 UNITS OF NOVOLOG BY INJECTION, AS SHE WAS NOT SURE IF HER SPIRIT BRAND INSULIN PUMP WAS WORKING PROPERLY. CUSTOMER THEN LAID DOWN TO REST AND HAD A SEIZURE AROUND 9 AM. HER SON CALLED THE EMTS, AND THEY ARRIVED IN LESS THAN 10 MINUTES. WHEN THEY ARRIVED, THEY TESTED CUSTOMER ON THEIR METER AT 40 MG/DL. THEY GAVE THE CUSTOMER GLUCAGON AND A SHOT, CUSTOMER DID NOT KNOW WHAT WAS IN THE SHOT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1074124 | SPIRIT INSULIN PUMP | PUMP, INFUSION, INSULIN | LZG | DISETRONIC MEDICAL SYSTEMS AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |