FDA Adverse Event
Malfunction
Summary report: N
ACCUDATA ® GTS PLUS
MDR report key: 2231429
·
Received September 1, 2011
Report
- Report Number
- 1823260-2011-04693
- Event Type
- Malfunction
- Date Received
- September 1, 2011
- Date of Event
- August 9, 2011
- Report Date
- October 5, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- CGA
- PMA / PMN Number
- K924475
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE ELECTRICAL SHORT WAS CAUSED BY ALCOHOL PADS GETTING LODGED BEHIND THE DRAWER AND COMING INTO CONTACT WITH THE AC INPUT.
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTED ALCOHOL PADS HAD GOTTEN LODGED BEHIND THE GTS STORAGE DRAWER, UNIT HAS SIGNS OF SCORCHING AND MELTED PLASTIC. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCUDATA ® GTS PLUS | BLOOD GLUCOSE MONITORING DEVICE | CGA | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |