FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH HORIZON TEST STRIPS
MDR report key: 17528096
·
Received August 12, 2023
Report
- Report Number
- MW5135027
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- March 5, 2013
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE ENCLOSED DOCUMENT IS OUR MONTHLY REPORT FOR COMPLAINTS RECEIVED BY LIFESCAN, INC., REGARDING COUNTERFEIT LIFESCAN DEVICE(S) (GLUCOSE TEST STRIPS) FOR THE MONTH OF (B)(6) 2013. THE SPREADSHEET LISTS COMPLAINTS BY STRIP LOT NUMBER AND CONTAINS LINE-ITEM LISTINGS FOR EACH COMPLAINT BY PRODUCT ISSUE (PI) #, ALERT DATE, PRODUCT NAME, LOT#, ADVERSE EVENT OR MALFUNCTION (BRIEF DESCRIPTION INCLUDED), AND COUNTRY WHERE THE COMPLAINT ORIGINATED (USA OR NON-USA). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596198 | ONE TOUCH HORIZON TEST STRIPS | GLUCOSE OXIDASE, GLUCOSE | CGA | LIFESCAN, INC. | 3305057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |