FDA Adverse Event
Malfunction
Summary report: N
OT ULTRALINK METER
MDR report key: 1875286
·
Received October 19, 2010
Report
- Report Number
- 2939301-2010-09227
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Report Date
- October 15, 2010
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT; 510(K)# IS K073231.
Description of Event or Problem · 1
THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER READ INACCURATELY HIGH WHEN COMPARED WITH ANOTHER METER, HOWEVER THE RESULTS WERE NOT SPECIFIED. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. 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. | 3035389 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |