FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 2810127
·
Received October 31, 2012
Report
- Report Number
- 1823260-2012-05533
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 7, 2012
- Report Date
- November 30, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K101299
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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
CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS: 1:46 AM: 87 MG/DL, 1:47 AM: 185 MG/DL, 1:48 AM: 101 MG/DL, 1:55 AM: 150 MG/DL, 2:06 AM: 143 MG/DL. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 490959 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 074 YR | NOVOLOG INSULIN| THEOPHYLLINE| NORVASC| BREATHING MACHINE| PRAVASTATIN| ADVAIR DISKUS| ALBUTEROL SULFATE| LANTUS INSULIN| LASIX| LISINOPRIL| SPIRIVA| METOPROLOL TARTRATE| ASPIRIN| CALTRATE VIT D| POTASSIUM CITRATE |