FDA Adverse Event
Malfunction
Summary report: N
I-STAT G3+ CARTRIDGE
MDR report key: 2091218
·
Received April 20, 2011
Report
- Report Number
- 2245578-2011-00052
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- March 28, 2011
- Report Date
- April 19, 2011
- Manufacturer
- ABBOTT POINT OF CARE CANADA LTD.
- Product Code
- JGS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT G3+ CARTRIDGE HAS BEEN YIELDING AN INCREASINGLY HIGH RATE OF CODE L WHILE RUNNING THE INTERNAL SIMULATOR ON THE I-STAT ANALYZER. LOT NUMBER: S10336; MFR DATE: 12/2010; EXP DATE: 07/2011. BASED ON THE INFO AT THE TIME, THERE WAS NO INJURY ASSOCIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | I-STAT G3+ CARTRIDGE | G3+ CARTRIDGE | JGS | ABBOTT POINT OF CARE CANADA LTD. | P10308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |