FDA Adverse Event
Malfunction
Summary report: N
RELION MICRO BLOOD GLUCOSE SYSTEM
MDR report key: 2100986
·
Received May 24, 2011
Report
- Report Number
- 1832816-2011-00028
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- April 26, 2011
- Report Date
- April 26, 2011
- Manufacturer
- ARKRAY, INC.
- Product Code
- CGA
- PMA / PMN Number
- K073416
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 RELION MICRO METER WAS GIVING VARIABLE READINGS. CUSTOMER GOT READING OF 371 AND THEN 89 WITHIN 10 MINUTES. DID NOT KNOW WETHER OR NOT TO TAKE INSULIN SO USED HIS BACK UP METER AND NO TREATMENT WAS GIVEN. CONTROLS NOT USED. REPLACING 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 | M105A03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |