FDA Adverse Event
Death
Summary report: N
OT SURESTEP METER
MDR report key: 724900
·
Received June 8, 2006
Report
- Report Number
- 2939301-2006-00836
- Event Type
- Death
- Date Received
- June 8, 2006
- Report Date
- May 9, 2006
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
LIFESCAN RECEIVED AN ALLEGATION THAT A ONE TOUCH SURESTEP METER CONTRIBUTED TO A DEATH. CURRENTLY, LIFESCAN IS INVESTIGATING THE COMPLAINT FURTHER; NO OTHER INFO WAS PROVIDED. LIFESCAN HAS TAKEN THE CONSERVATIVE APPROACH TO CLASSIFY THIS CASE AS AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT SURESTEP METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |