FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 247813
·
Received October 29, 1999
Report
- Report Number
- 2939301-1999-00944
- Event Type
- Malfunction
- Date Received
- October 29, 1999
- Report Date
- October 8, 1998
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THAT HIS SON HAD DONE A BG METER TEST ON HIM AND RECEIVED AN ER1 MESSAGE. HE SAID HE WENT TO THE HOSP BECAUSE HE WAS NOT FEELING WELL AND HIS BG WAS >500 MG/DL. THE REPORTER STATED THAT HE HAS NO SHORT TERM MEMORY AND DOES NOT KNOW HOW TO CONTACT HIS SON. HIS STATEMENTS WERE INCONSISTENT. HE GAVE THE METER MEMORY ON 10/8/1998 AS 145, 191, 167, 190, 213, 134, 318, 160, 130, AND 154. ON FOLLOW UP, A CONTROL SOLUTION RESULT WAS IN RANGE, (126) 89-133. NO FURTHER INFO WAS PROVIDED. NO HARM WAS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESTEP | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CGA | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |