FDA Adverse Event
Malfunction
Summary report: N
OT ULTRALINK METER
MDR report key: 2240269
·
Received September 9, 2011
Report
- Report Number
- 2939301-2011-08694
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Report Date
- August 30, 2011
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN (LFS) HAS REQUESTED NOT RETURN OF THE SUBJECT PRODUCT(S), THE CUSTOMER DOES NOT HAVE THEM ANYMORE; 510(K)# IS K073231.
Description of Event or Problem · 1
THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE ALLEGEDLY THERE WAS A BLACK TEST STRIP FOUND IN A BLUE TEST STRIP VIAL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT ULTRALINK METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |