FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK VOICEMATE
MDR report key: 1111676
·
Received August 13, 2008
Report
- Report Number
- 1823260-2008-06170
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- July 29, 2008
- Report Date
- August 13, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K982079
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
CALLER STATES THE VOICEMATE SYSTEM SPOKE A RESULT OF 2.6. CUSTOMER DID NOT KNOW OF MMOL/L ACCOMPANIED THE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
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 | 75 YR | LISINOPRIL - 40MG/DAY| LORAZEPAM 1MG/DAY| METFORMIN - 1000MG/DAY| LIPITOR 40MG/DAY| TOPROL 50MG/DAY| "HYDROPEROXIDINE" - 50MG/DAY |