FDA Adverse Event
Injury
Summary report: N
ASSURE 4 BLOOD GLUCOSE SYSTEM
MDR report key: 1740603
·
Received June 29, 2010
Report
- Report Number
- 1832816-2010-00014
- Event Type
- Injury
- Date Received
- June 29, 2010
- Date of Event
- June 3, 2010
- Report Date
- June 3, 2010
- Manufacturer
- APEX BIOTECHNOLOGY CORP.
- Product Code
- NBW
- PMA / PMN Number
- K070088
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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. CUSTOMER DID NOT RETURN PRODUCT.
Description of Event or Problem · 1
CALLER INDICATED THE ASSURE 4 METER WAS READING HIGH. AROUND 7:30AM ON (B) (6) 2010, PATIENT HAD A FASTING READING OF 100 BUT SHOWED SYMPTOMS OF LOW BLOOD SUGAR. EMS CALLED- ON ARRIVAL, PATIENT TESTED WITH A RESULT OF 22.
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 | SS038I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |