FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® NANO
MDR report key: 3120469
·
Received May 20, 2013
Report
- Report Number
- 1823260-2013-03057
- Event Type
- Malfunction
- Date Received
- May 20, 2013
- Date of Event
- March 4, 2013
- Report Date
- June 25, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K113137
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
UPON REVIEW BY THE MANUFACTURER'S INVESTIGATION UNIT, THE NANO METER SHOWED SIGNS OF AN ELECTRICAL SHORT. THE INTERNAL DISPLAY HAD A DARKENED SPOT AT THE TOP THAT APPEARS TO BE MELTED, AND THE METER HAD A "BURNT SMELL". NO ADVERSE EVENT REPORTED. SUSPECT DEVICE WAS RETURNED AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222686 | ACCU-CHEK ® NANO | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |