FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 273003
·
Received April 5, 2000
Report
- Report Number
- 2939301-2000-00242
- Event Type
- Malfunction
- Date Received
- April 5, 2000
- Report Date
- March 8, 2000
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE RPTR STATED THAT RPTR DID BACK TO BACK BLOOD GLUCOSE TESTS. RESULTS WERE 59, 139, 132, 104 AND 62 MG/DL. RPTR DID NOT HAVE ANY SYMPTOMS. A CONTROL TEST WAS NOT DONE DUE TO A LACK OF SUPPLIES. ON FOLLOWUP, THE RPTR STATED THAT RPTR HAD NOT USED THE METER FOR OVER TWO YEARS. RPTR'S TEST STRIPS HAD BEEN OPEN FOR MORE THAN 4 MONTHS, AND RPTR'S CONTROL SOLUTION WAS EXPIRING. THE RPTR OPENED A NEW VIAL OF STRIPS AND HAD 'GOOD' READINGS. 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 | 57 YR | Other |