FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 2413717
·
Received January 12, 2012
Report
- Report Number
- 1823260-2012-00265
- Event Type
- Malfunction
- Date Received
- January 12, 2012
- Date of Event
- December 19, 2011
- Report Date
- February 2, 2012
- 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
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THIS MEDWATCH IS FOR THE AVIVA SYSTEM 2. REFERENCE MEDWATCH WITH (B)(6) FOR THE AVIVA SYSTEM 1.
Description of Event or Problem · 1
CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 537 MG/DL (AVIVA SYSTEM 1) AND 248 MG/DL (AVIVA SYSTEM 2). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, 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 | 303426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 053 YR | CYMBALTA| NEURONTIN| ASPIRIN| HUMALOG| LANTUS| PRILOSEC| "HYDROXYCHLOROQIN"| SEROQUEL| LORATADINE| ETODOLAC| ABILIFY| "SIMILIN"| SYNTHROID| HYZAR| ZOCOR |