FDA Adverse Event
Malfunction
Summary report: N
GLUCOCARD 01 BLOOD GLUCOSE SYSTEM
MDR report key: 2082067
·
Received May 9, 2011
Report
- Report Number
- 1832816-2011-00022
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- April 17, 2011
- Report Date
- April 18, 2011
- Manufacturer
- ARKRAY, INC.
- Product Code
- CGA
- PMA / PMN Number
- K073416
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. NO FAILURE DETECTED.
Description of Event or Problem · 1
CALLER INDICATED THE GLUCOCARD 01 METER WAS GIVING VARIABLE READINGS. CALLER STATES HE GOT 55 AND TRIED AGAIN COUPLE SECONDS LATER AND GOT 456. WASHED HIS HANDS AND HAD NOT EATEN WITHIN 2 HOURS. (B)(6) STATED HE KEEPS STRIPS IN THE BATHROOM. EDUCATED CUSTOMER ON PROPER STORAGE CONDITIONS. CONTROLS USED ARE IN RANGE. REPLACING PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GLUCOCARD 01 BLOOD GLUCOSE SYSTEM | BLOOD GLUCOSE TEST SYSTEM | CGA | ARKRAY, INC. | 720050 | G104A18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |