FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 241481
·
Received September 16, 1999
Report
- Report Number
- 2939301-1999-00754
- Event Type
- Malfunction
- Date Received
- September 16, 1999
- Report Date
- August 17, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 DID BACK TO BACK BLOOD GLUCOSE TESTS AND GOT RESULTS OF 199, 208, 89 AND 198 MG/DL. HE DID NOT HAVE ANY SYMPTOMS. REPORTER DID NOT HAVE NEW TEST STRIPS OR CONTROL SOLUTION FOR TESTING. ON FOLLOW-UP, REPORTER STATED THAT HE DID BACK TO BACK TESTING AND GOT RESULTS OF 178 AND 101 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES, USING 2 FINGERSTICKS. REPORTER STATED THAT HE SQUEEZES HIS FINGER "QUITE A LOT" TO GET A BLOOD SAMPLE. HE DID A CONTROL SOLUTION TEST THAT WAS IN RANGE 131 (100-149).
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 | UNKNOWN | Other |