FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INFORM METER
MDR report key: 1722399
·
Received June 14, 2010
Report
- Report Number
- 1823260-2010-03552
- Event Type
- Malfunction
- Date Received
- June 14, 2010
- Date of Event
- June 8, 2010
- Report Date
- June 25, 2010
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K012210
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B) (6).
Description of Event or Problem · 1
HEALTH CARE FACILITY REPORTED THAT A MALE PT WITH HEART FAILURE AWAITING A TRANSPLANT HAD YELLOW MALODOROUS DISCHARGE AROUND THE CATHETER AND UNDER THE DRESSING. THE FACILITY REPORTED THAT THE CATHETER WAS REMOVED AND CULTURES WERE TAKEN, ALL CULTURES RETURNED NEGATIVE. THE FACILITY REPORTED THAT THE SKIN WAS REDDENED UNDER THE DISCHARGE. THE FACILITY REPORTED THAT THE SKIN REACTION IS IMPROVING.
Description of Event or Problem · 1
REPORTER ALLEGED THAT THE INFORM METER HAD MELTED, BLACKENED PLASTIC ON THE BOTTOM OF THE METER. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE, AND A REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® INFORM METER | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |