FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK INFORM METER
MDR report key: 1344900
·
Received March 16, 2009
Report
- Report Number
- 1823260-2009-02036
- Event Type
- Injury
- Date Received
- March 16, 2009
- Date of Event
- March 2, 2009
- Report Date
- March 16, 2009
- Manufacturer
- ROCHE DIAGNOSTICS CORP.
- Product Code
- NBW
- PMA / PMN Number
- K012210
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CALLER REPORTED 2 PT BLOOD GLUCOSE TESTS PERFORMED WITH INFORM SYSTEM AT 10:05 AM, THE RESULT OF EACH TEST WAS "ERROR #83 ERROR: EXTREMELY LOW BLOOD GLUCOSE SAMPLE BELOW THE METER'S READING RANGE OR A BAD STRIP. REPEAT TEST OR FOLLOW YOUR FACILITY'S POLICY". CALLER STATED PT WAS TREATED WITH DEXTROSE BASED ON THIS ERROR MESSAGE DESCRIPTION WITH THE ASSUMPTION HIS BLOOD GLUCOSE WAS VERY LOW. AT ABOUT 10:20 AM, A LAB SAMPLE WAS DRAWN; LAB RESULT WAS 1084. DEXTROSE IV DISCONTINUED AT 10:35 AM. AT ABOUT 11:00 AM, A LAB SAMPLE WAS DRAWN; LAB RESULT WAS 1319. THE PT WAS TREATED WITH IN INSULIN IV AT AN UNSPECIFIED TIME. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK INFORM METER | BLOOD GLUCOSE MONITORING DEVICE -NBW | NBW | ROCHE DIAGNOSTICS CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention | DEXTROSE 5% IV| GLUCOPHAGE| DEXTROSE 50%| INSULIN IV |