FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 2191698
·
Received August 4, 2011
Report
- Report Number
- 1823260-2011-04194
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- April 25, 2011
- Report Date
- August 4, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K043474
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER CAREGIVERS
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: 518 MG/DL AND 156 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, CUSTOMER NO LONGER HAS THE STRIPS. 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 089 YR | FIBER PILL - TYPE UNKNOWN, 2X DAILY| FLOMAX 1X DAILY| OXYGEN, AS NEEDED BASIS| ARICEPT 1X DAILY| ASPIRIN 1X DAILY| MULTIVITAMIN| MAXZIDE 1X DAILY| LANTUS 1X DAILY |