FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 2823424
·
Received November 7, 2012
Report
- Report Number
- 1823260-2012-05659
- Event Type
- Malfunction
- Date Received
- November 7, 2012
- Date of Event
- October 12, 2012
- Report Date
- November 7, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K101299
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE AVIVA SYSTEM 2. REFERENCE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE AVIVA SYSTEM 1. WILL NOT BE RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS ON TWO METERS WITHIN 10 MINUTES: 449 MG/DL (AVIVA SYSTEM 1) AND 83 MG/DL (AVIVA SYSTEM 2). CUSTOMER WAS NOT FEELING WELL AT THE TIME OF THE READINGS, AND SELF- TREATED BASED UPON THE READING OF 83 MG/DL WITH 8 UNITS OF LANTUS, AND AN UNKNOWN AMOUNT OF HUMALOG. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS; HOWEVER, CUSTOMER NO LONGER HAS THE STRIPS. REPLACEMENT WAS 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 068 YR | LANTUS| MIRALAX| CRESTOR 1X NIGHTLY| HUMALOG| LACTULOSE| LISINOPRIL| BABY ASPIRIN 1X DAILY |