FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 239992
·
Received September 8, 1999
Report
- Report Number
- 2939301-1999-00721
- Event Type
- Malfunction
- Date Received
- September 8, 1999
- Report Date
- August 9, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 SHE DID A METER TO HCP METER COMPARISON. HER METER READING WAS 147 MG/DL, AND THE DOCTOR'S METER (AMES) RESULT WAS 222 MG/DL. THE TESTS WERE BOTH CAPILLARY, AND DONE WITHIN FIVE MINUTES OF EACH OTHER, USING SEPARATE FINGER STICKS. THE REPORTER DID NOT HAVE ANY SYMPTOMS. A CONTROL TEST RESULT WAS IN RANGE, 128 (101-151). ON FOLLOW-UP A CONTROL SOLUTION TEST WAS DONE WITH A RESULT OF 140 (101-151). THE LIFESCAN REPRESENTATIVE DID TRAINING 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 | 74 YR | Other |