FDA Adverse Event
Malfunction
Summary report: N
ASSURE PLATINUM BLOOD GLUCOSE SYSTEM
MDR report key: 2068818
·
Received April 25, 2011
Report
- Report Number
- 1832816-2011-00017
- Event Type
- Malfunction
- Date Received
- April 25, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 4, 2011
- Manufacturer
- ARKRAY, INC.
- Product Code
- CGA
- PMA / PMN Number
- K092104
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 ASSURE PLATINUM METER WAS GIVING VARIABLE READINGS. NURSE GOT THE FOLLOWING READINGS WITHIN 10 MINUTES 182, 548, 170, 151, 548. NURSE THEN TESTED WITH ANOTHER METER AND STRIPS AND GOT ACCURATE AND CONSISTENT READINGS, PATIENT DID NOT NEED ANY TREATMENT. CONTROLS USED ARE IN RANGE. REPLACING PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASSURE PLATINUM BLOOD GLUCOSE SYSTEM | BLOOD GLUCOSE TEST SYSTEM | CGA | ARKRAY, INC. | 500050 | 12130A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |