FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 2012348
·
Received March 9, 2011
Report
- Report Number
- 1823260-2011-01297
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 27, 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
- MO, 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 REPORTED LOW BLOOD GLUCOSE SYMPTOMS WITH RESULT OF 133 MG/DL OBTAINED ON THE AVIVA SYSTEM. CUSTOMER STATES SHE HAD USED LEVEL 1 CONTROL SOLUTION ON HER FINGER BELIEVING IT WAS HAND SANITIZER. CUSTOMER'S SPOUSE TREATED HER WITH TWO BOOST GLUCOSE MILKSHAKES, WHICH SHE WAS ABLE TO CONSUME ON HER OWN. LOW BLOOD GLUCOSE SYMPTOMS IMPROVED APPROXIMATELY 2 HOURS LATER. NO ADVERSE EVENT RELATED TO THE DEVICE WAS 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 | 303049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 057 YR | LOMOTIL| HYOSCYAMINE| ESTRADIOL| "LEVINTHYROID"| PROZAC| FIORINAL| GLUCOPHAGE| KLONOPIN| LEVEMIR FLEXPEN| "MAXINE"| COLOSTOMY BAG| BUSPAR| FLEXERIL| ULTRAM| OMEGA 3| POTASSIUM| B-12 INJECTIONS| PROACTAZYME PLUS| GLUCOSAMINE CHONDROITIN| PRILOSEC |