FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 2970383
·
Received February 20, 2013
Report
- Report Number
- 1823260-2013-01092
- Event Type
- Malfunction
- Date Received
- February 20, 2013
- Date of Event
- February 2, 2013
- Report Date
- July 29, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K101299
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- N
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. ALL RESULTS MG/DL. HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL AT 1:18PM 549 AT 1:20PM 260 AT 1:22PM 506 AT 1:25PM 201 AT 1:26PM 91 AT 1:27PM 120 AT 1:35PM 455 AT 1:36PM 176 AT 1:42PM 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 |
|---|---|---|---|---|---|---|---|
| 74033 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 491355 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Male | LANTUS| NOVOLOG| LANTUS| NOVOLOG |