FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 225982
·
Received May 26, 1999
Report
- Report Number
- 2939301-1999-00348
- Event Type
- Malfunction
- Date Received
- May 26, 1999
- Report Date
- April 27, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 RPTR STATED THAT SHE HAD DONE BLOOD GLUCOSE TESTING AND GOT A RESULT OF 209 MG/DL. SHE RETESTED, WITHIN MINUTES, AND GOT A RESULT OF 104 AND 102 MG/DL. SHE REPORTED THAT SHE HAD BEEN HAVING HEADACHES, AND HAD BEEN UNDER EXTREME STRESS. A CONTROL SOLUTION TEST WAS IN RANGE, 95-143 (126). DURING A FOLLOW UP CALL, THE RPTR STATED THAT SHE HAD A LAB TO HCP METER COMPARISON DONE SINCE HER INITIAL REPORT, AND THAT HER METER RESULT OF 113 MG/DL WAS HIGHER THAN THE LAB'S 82 MG/DL. NO FURTHER DETAILS OF THE COMPARISON TEST WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESTEP | BLOOD GLUCOSE METER | CGA | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |