FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING METER
MDR report key: 1232154
·
Received November 4, 2008
Report
- Report Number
- 2939301-2008-02944
- Event Type
- Malfunction
- Date Received
- November 4, 2008
- Report Date
- October 22, 2008
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED 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
THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT WAS PROMPTING THE APPLY SAMPLE MESSAGE, WHICH WAS UNRESOLVED WITH TROUBLESHOOTING. THIS WAS NOT A NEW OUT OF BOX PRODUCT AND THE TESTING TECHNIQUE WAS CORRECT. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN, INC. | NA | 2854421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |