FDA Adverse Event
Injury
Summary report: N
RELION MICRO BLOOD GLUCOSE SYSTEM
MDR report key: 2111934
·
Received June 2, 2011
Report
- Report Number
- 1832816-2011-00031
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- May 9, 2011
- Report Date
- May 10, 2011
- Manufacturer
- ARKRAY, INC.
- Product Code
- CGA
- PMA / PMN Number
- K073416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE ALSO TESTED AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.
Description of Event or Problem · 1
CALLER INDICATED THE RELION MICRO METER WAS READING HIGH. STATES SHE WAS GETTING 486, 399 WITH MICRO METER AND 324 WITH BREEZE2 METER. TOOK 40 UNITS OF INSULIN. SHE DID STATE SHE WAS USING SAME LANCET. SHE FELT CRABBY, TIRED THIRSTY, AND HUNGRY PRIOR TO READINGS. 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 | A115A04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Life Threatening |