FDA Adverse Event
Injury
Summary report: N
ASSURE 4 BLOOD GLUCOSE SYSTEM
MDR report key: 1731547
·
Received June 22, 2010
Report
- Report Number
- 1832816-2010-00010
- Event Type
- Injury
- Date Received
- June 22, 2010
- Date of Event
- May 20, 2010
- Report Date
- May 24, 2010
- Manufacturer
- APEX BIOTECHNOLOGY CORP.
- Product Code
- NBW
- PMA / PMN Number
- K070088
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE TESTED AND PERFORMED TO SPECIFICATION. NOT RETURNED FOR EVALUTION.
Description of Event or Problem · 1
CALLER INDICATED THE ASSURE 4 WAS READING HIGH. PT TOOK READING AT 6:00AM WITH A RESULT OF 70 ABOUT 15 MIN LATER, AMBULANCE ARRIVED, IT WAS A READING OF 38. METER TESTED WITH CONTROL SOLUTION IN RANGE. OMAPRAZOL BEFORE READING OF 70. (B) (6). USUAL READINGS OF 120-130.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASSURE 4 BLOOD GLUCOSE SYSTEM | BLOOD GLUCOSE TEST SYSTEM | NBW | APEX BIOTECHNOLOGY CORP. | 560050 | SS038A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |