FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 247917
·
Received October 28, 1999
Report
- Report Number
- 2939301-1999-00880
- Event Type
- Malfunction
- Date Received
- October 28, 1999
- Report Date
- September 30, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
METER WAS NOT THE SUBJECT OF FDA RECALL Z-631-8
Description of Event or Problem · 1
THE REPORTER STATED THAT SHE DID A METER TO LAB COMPARISON TEST, 1 TO 2 HOURS APART. SHE HAD EATEN BREAKFAST AN HOUR BEFORE THE VENOUS LAB DRAW. THE METER TEST (CAPILLARY) WAS DONE AT HOME, WITH A READING OF 150 OR 152 MG/DL. SHE BELIEVES SHE HAD A GOOD SAMPLE ON THE STRIP, BUT IT WAS UNCERTAIN IF IT WAS INSERTED COMPLETELY. THE LAB TEST RESULT WAS 210 MG/DL. SHE DID NOT HAVE ANY SYMPTOMS. A CONTROL TEST WAS NOT DONE DUE TO UNAVAILABILITY OF CONTROL SOLUTION. ON FOLLOWUP, A CONTROL TEST WAS IN RANGE, 137 (102-154). THE LIFESCAN REPRESENTATIVE REVIEWED CLEANING AND COMPARING METER TO LAB RESULTS.
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 | 75 YR | Other |