FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MOBILE TEST STRIPS
MDR report key: 2040223
·
Received April 5, 2011
Report
- Report Number
- 1823260-2011-01893
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- April 3, 2011
- Report Date
- May 31, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(4). CALLER DID NOT PROVIDE PRODUCT INFORMATION FOR THE AVIVA NANO SYSTEM.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED RESULTS OF 11.0 MMOL/L (17:02) AND 17.1 MMOL/L (17:07) ON THE MOBILE SYSTEM. CUSTOMER RE-TESTED ON AN AVIVA NANO AND RECEIVED RESULTS OF 5.4 MMOL/L (17:08) AND 3.7 MMOL/L (17:17). 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 ® MOBILE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 278007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 012 YR | NOVORAPID |