FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 251786
·
Received November 24, 1999
Report
- Report Number
- 2939301-1999-00996
- Event Type
- Malfunction
- Date Received
- November 24, 1999
- Report Date
- October 26, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, 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 163, 109 AND 142 MG/DL. TESTS WERE DONE ONE AFTER THE OTHER. THE SAME FINGERSTICK WAS USED FOR THE LAST TWO TESTS. REPORTER STATED THAT FOR A FEW DAYS HER BLOOD GLUCOSE HAD BEEN HIGHER THAN NORMAL AND SHE HAD SYMPTOMS OF HUNGER, IRRITABILITY AND A SWEET TASTE IN HER MOUTH EVERY TIME SHE ATE. AFTER THE SYMPTOMS DISAPPEARED, HER BLOOD SUGAR LOWERED. SHE DID NOT HAVE CONTROL SOLUTION FOR TESTING. ON FOLLOW-UP, REPORTER STATED THAT SHE WILL BE TAKING HER METER WITH HER TO THE DR'S OFFICE FOR A METER/LAB COMPARISON TEST.
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 | 61 YR | Other |