FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 244894
·
Received October 12, 1999
Report
- Report Number
- 2939301-1999-00826
- Event Type
- Malfunction
- Date Received
- October 12, 1999
- Report Date
- September 11, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, 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 BACK TO BACK BLOOD GLUCOSE TESTING, WITHIN 10 MINUTES, USING SEPARATE FINGER STICKS. HER RESULTS WERE 338, 141, 135 AND 131 MG/DL. SHE DID NOT HAVE ANY SYMPTOMS. THE REPORTER'S CONTROL SOLUTION WAS EXPIRED, AND SHE DID NOT HAVE TEST STRIPS AVAILABLE FOR CONTROL TESTING. SHE IS FAMILIAR WITH CODING, CONTROL, AND THE LIFESCAN REPRESENTATIVE REVIEWED CLEANING. THE REPORTER WILL CALL BACK IF FURTHER PROBLEMS AFTER RECEIVING NEW SUPPLIES.
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 | 44 YR | Other |