FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK VOICEMATE
MDR report key: 1060123
·
Received June 10, 2008
Report
- Report Number
- 1823260-2008-04617
- Event Type
- Malfunction
- Date Received
- June 10, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 10, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K982079
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
THE CUSTOMER STATES THAT THE ACCU-CHEK ADVANTAGE SCREEN DISPLAYED 86 MG/DL WHILE THE ACCU-CHEK VOICEMATE SPOKE 170 MG/DL OR 189 MG/DL. NO REPORTED ACTIONS TAKEN. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT AND RETURN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK VOICEMATE | BLOOD GLUCOSE MONITORING DEVICE - LFR | LFR | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | LEVOXYL 75MG/DAY - SUNDAY-37.5MG-4 YEARS| NOVOLOG SLIDING SCALE - 3X/DAY-4-5 YEARS| CELLCEPT 1000MG/DAY - 6 MONTHS| SANDIMMUNE 50MG/DAY| ENALAPRIL 20MG/UNK FREQ - LONG TIME-INCREASED| ECOTRIN 81MG/DAY - SEVERAL YEARS| PRILOSEC UNK DOSE/ DAILY - 4-5 YEARS| LANTUS 18 UNITS/DAY - 4-5 YEARS| SODIUM BICARBONATE - 20 GRAMS/DAY-3 MONTHS| PREDNISONE 7.5MG/DAY |