FDA Adverse Event
Malfunction
Summary report: N
I-STAT ACT KAOLIN CARTRIDGE
MDR report key: 1821320
·
Received August 26, 2010
Report
- Report Number
- 2245578-2010-00111
- Event Type
- Malfunction
- Date Received
- August 26, 2010
- Date of Event
- July 26, 2010
- Report Date
- August 25, 2010
- Manufacturer
- ABBOTT POINT OF CARE CANADA LTD.
- Product Code
- JBP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT ACT KAOLIN CARTRIDGE DISPLAYED A BLANK SCREEN INSTEAD OF YIELDING RESULTS. ANALYZER CUSTOMIZATION VERIFIED AND ACT TESTING WAS ENABLED. BASED ON THE INFO AT THIS TIME THERE IS NO INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | I-STAT ACT KAOLIN CARTRIDGE | ACT K CARTRIDGE | JBP | ABBOTT POINT OF CARE CANADA LTD. | S10101D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |