D
Patient 1
THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER. UPON INVESTIGATION, THE METER WAS FOUND TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.
MAUDE MDR 1803801
- MDR report key
- 1803801
- Report number
- 2954323-2007-15802
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-07-06
- Date received
- 2007-08-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- TINA MAZURKIEWICZ
- Address
- 1360 SOUTH LOOP RD. ALAMEDA CA 94502 US
- Phone
- 508-508-5087
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE FLASH | BLOOD GLUCOSE MONITORING SYSTEM | ABBOTT DIABETES CARE INC, USA | LFR | NI | 17001 | NI | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-08-28 | 0 |
Event Narratives#
N
Patient 1
(B)(4). THE METER HAS BEEN CONFIRMED TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.