FDA Adverse Event
Malfunction
Summary report: N
RELION MICRO BLOOD GLUCOSE SYSTEM
MDR report key: 2232140
·
Received September 2, 2011
Report
- Report Number
- 1832816-2011-00068
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 7, 2011
- Report Date
- August 8, 2011
- Manufacturer
- ARKRAY, INC.
- Product Code
- NBW
- PMA / PMN Number
- K082417
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 TOOK BG LEVELS FIRST THING IN THE MORNING BEFORE EATING/DRINKING ANY THING AND THE RESULT WERE 91MG/DL WHICH CAUSED CALLER TO RETEST, AND THE NEXT RESULT WAS 336MG/DL ABOUT 5-6 MINUTES LATER. CALLER LATER WENT TO PHARMACY FOR ADVICE, WHERE THE PHARMACIST SUGGESTED HE TAKE INSULIN. CALLER STATED THAT HE DID NOT TAKE ANY. CUSTOMER DOES NOT HAVE CONTROLS. SENDING SOLUTION AND REPLACING PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RELION MICRO BLOOD GLUCOSE SYSTEM | BLOOD GLUCOSE TEST SYSTEM | NBW | ARKRAY, INC. | 710001 | C115A12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |