FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 2052279
·
Received April 12, 2011
Report
- Report Number
- 1823260-2011-02012
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- April 4, 2011
- Report Date
- June 6, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K043474
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 259 MG/DL AND 109 MG/DL WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 303033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 084 YR | DILTIAZEM 1XDAY| BLOOD PRESSURE MACHINE| METFORMIN| PREDNISONE| ALENDRONATE| HYDROCHLOROTHIAZDE 1XDAY| TRAVATAN| WARFARIN 1XDAY| LEVOXYL 1XDAY| FLUOROMETHOLONE| DIGOXIN 1XDAY |