FDA Adverse Event
Malfunction
Summary report: N
SIDEKICK
MDR report key: 3022958
·
Received March 21, 2013
Report
- Report Number
- 1052693-2013-00022
- Event Type
- Malfunction
- Date Received
- March 21, 2013
- Date of Event
- February 25, 2013
- Report Date
- March 21, 2013
- Manufacturer
- NIPRO DIAGNOSTICS INC
- Product Code
- NBW
- PMA / PMN Number
- K051147
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT NOT YET RETURNED FOR EVAL. INTERNAL REPORT #(B)(4).
Description of Event or Problem · 1
CONSUMER COMPLAINT OF HIGH BLOOD RESULT (271MG/DL). CONTROL TEST RESULT WAS IN RANGE. CALLER DOES NOT TRUST THE PRODUCT. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118837 | SIDEKICK | BLOOD GLUCOSE SYSTEM | NBW | NIPRO DIAGNOSTICS INC | SIDEKICK | SN4042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |