FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 251307
·
Received November 18, 1999
Report
- Report Number
- 2939301-1999-00974
- Event Type
- Malfunction
- Date Received
- November 18, 1999
- Report Date
- October 19, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
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 HE DID BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN 10 MINUTES, USING SEPARATE FINGER STICKS. HIS RESULTS WERE 203, 171, 117 MG/DL. HE DID NOT HAVE ANY SYMPTOMS. CONTROL TESTING WAS NOT DONE DUE TO LACK OF SUPPLIES. ON FOLLOW UP, THE REPORTER STATED HE HAD DONE A CONTROL TEST WITH A RESULT OF 123 MG/DL, WHICH WAS IN RANGE. THE LIFESCAN REPRESENTATIVE REVIEWED COVERAGE, CLEANING, CODING AND STORAGE WITH THE REPORTER.
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 |