FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 277376
·
Received May 9, 2000
Report
- Report Number
- 2939301-2000-00385
- 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE RPTR DID BACK TO BACK (RAPID SUCCESSION) BLOOD GLUCOSE TESTS. PT'S RESULTS WERE 230, 320 AND 284 MG/DL. PT DID NOT HAVE ANY SYMPTOMS. METER CODE/STRIP WAS INCORRECT; REVIEWED METER SETTING. A CONTROL TEST WAS NOT DONE DUE TO UNAVAILABILITY OF SUPPLIES. ON FOLLOWUP, PT WAS CONCERNED THAT THE RESULTS WERE ELEVATED BECAUSE THE DR WANTS PT'S BLOOD GLUCOSE TO BE BETWEEN 87 AND "MAYBE 138". PT IS ON GLYBURIDE. 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 | 64 YR | Other |