FDA Adverse Event
Malfunction
Summary report: N
ASSURE PRO BLOOD GLUCOSE MONITOR
MDR report key: 2080069
·
Received May 6, 2011
Report
- Report Number
- 1832816-2011-00021
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Date of Event
- April 7, 2011
- Report Date
- April 7, 2011
- Manufacturer
- UL-TECH ELECTRONICS
- Product Code
- CGA
- PMA / PMN Number
- K090332
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METER INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED METER READ HIGH ON SOLUTION AND READ LOW ON 80 LEVEL OF BLOOD TESTING, CONFIRMING THE COMPLAINT. SPECIFIC ROOT CAUSE IS UNKNOWN, THEREFORE PRODUCT WILL BE SENT TO THE MANUFACTURER FOR FURTHER EVALUATION AND POSSIBLE CORRECTIVE ACTION.
Description of Event or Problem · 1
CALLER INDICATED THE ASSURE PRO WAS READING LOW ON BLOOD AND HIGH ON CONTROL SOLUTION. REPLACED PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASSURE PRO BLOOD GLUCOSE MONITOR | BLOOD GLUCOSE MONITOR | CGA | UL-TECH ELECTRONICS | 460001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |