FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 2170592
·
Received July 21, 2011
Report
- Report Number
- 1823260-2011-03876
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- July 2, 2011
- Report Date
- August 3, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K043474
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. CUSTOMER REPORTED TWO STRIP LOTS THAT MAY HAVE PRODUCED THE DISCREPANT RESULTS. CUSTOMER DOES NOT HAVE PRODUCT INFORMATION FOR THE SECOND SUSPECT SYSTEM AND NO LONGER HAS THE TEST STRIPS.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 575 MG/DL, 69 MG/DL, 105 MG/DL, AND 65 MG/DL. CUSTOMER CONSUMED CEREAL ON HER OWN AFTER OBTAINING THE REPORTED 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 | 303116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 064 YR | PREDNISONE ONCE DAILY| NEBULIZER| "ZANTAX" ONCE DAILY| AMITIZA TWICE DAILY| SIMVASTATIN ONCE DAILY| MUCINEX TWICE DAILY| VITAMIN D ONCE DAILY| POTASSIUM "CLER" 3/DAILY| PLAVIX ONCE DAILY| LASIX TWICE DAILY| METOPROLOL TWICE DAILY| NORVASC TWICE DAILY| NOVOLOG| AEROSOL MACHINE| RENVELA 3 TIMES DAILY| LANTUS| NEURONTIN 3 TIMES DAILY| HYDRALAZINE 3 TIMES DAILY| CELEXA ONCE DAILY| OXYGEN MACHINE| MULTIVITAMIN DAILY| BABY ASPIRIN ONCE DAILY |