FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 2071919
·
Received April 28, 2011
Report
- Report Number
- 1823260-2011-02303
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- April 14, 2011
- Report Date
- June 15, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K043474
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
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: 158 MG/DL AND 55 MG/DL. CUSTOMER IS INCOHERENT AND CANNOT SELF-TREAT. CUSTOMER'S HUSBAND TREATED THE CUSTOMER WITH COOKIES AND GLUCOSE TABLETS. 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 | 303027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 053 YR | "METANX"| COZAR| VERAPAMIL| LORATAB| FOLBIC| MULTIGEN PLUS| CALCITROL| ZOCOR| POTASSIUM CL| LANTUS| NOVOLOG |