FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 2000384
·
Received February 24, 2011
Report
- Report Number
- 1823260-2011-01016
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- February 10, 2011
- Report Date
- March 17, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K043474
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, 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
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 502 MG/DL, 245 MG/DL, 201 MG/DL, 210 MG/DL, 225 MG/DL, 172 MG/DL AND 187 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 ® AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 302334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 063 YR | DIOVAN 1 TABLET DAILY| NEXIUM 1 TABLET| LIPITOR 1 TABLET DAILY| "OXYCODIN"| CYMBALTA 1 TABLET DAILY| BABY ASPIRIN| GLIPIZIDE 2 TABLETS DAILY |