FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 277367
·
Received May 9, 2000
Report
- Report Number
- 2939301-2000-00380
- Event Type
- Malfunction
- Date Received
- May 9, 2000
- Report Date
- April 12, 2000
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE RPTR, A PHARMACIST, STATED THAT CUSTOMER DID METER TO LAB COMPARISON TESTS, 30 MINS APART. THE REPORTED METER READING WAS 112 MG/DL, AND LAB TEST RESULT WAS 143 MG/DL. NO SYMPTOMS WERE REPORTED. ON FOLLOWUP, THE METER OWNER CONFIRMED THE REPORTED RESULTS; HOWEVER, THE TEST WAS A COMPARISON TEST TO CUSTOMER'S DR'S METER (TYPE UNKNOWN). CUSTOMER HAD TESTED FASTING AT HOME AT 7:45AM, AND SAW THE DR AT 8:30AM. THREE HOURS LATER, CUSTOMER TESTED BACK TO BACK ON THE METER WITH RESULTS OF 100, 117, 119 MG/DL. 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 | 77 YR | Other |