FDA Adverse Event
Malfunction
Summary report: N
RELION MICRO BLOOD GLUCOSE SYSTEM
MDR report key: 2132155
·
Received June 17, 2011
Report
- Report Number
- 1832816-2011-00038
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 19, 2011
- Manufacturer
- ARKRAY, INC.
- Product Code
- CGA
- PMA / PMN Number
- K073416
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE METER INVOLVED IN INCIDENT WAS RETURNED, BUT THE TEST STRIPS WERE NOT RETURNED AND LOT NUMBER IS NOT KNOWN. THE RETURNED METER WAS EVALUATED WITH REFERENCE TEST STRIPS AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.
Description of Event or Problem · 1
CALLER INDICATED THE RELION MICRO METER WAS GIVING VARIABLE READINGS. READINGS OF 24, 197, AND 247 ALL WITH IN 10 MINUTES WITH PROPER TECHNIQUE. CONTROLS NOT USED. REPLACED PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RELION MICRO BLOOD GLUCOSE SYSTEM | BLOOD GLUCOSE TEST SYSTEM | CGA | ARKRAY, INC. | 710050 | A115A11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |