FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MOBILE TEST STRIPS
MDR report key: 4220171
·
Received November 3, 2014
Report
- Report Number
- 1823260-2014-08444
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- September 26, 2014
- Report Date
- November 2, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. (B)(4). DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT SYSTEMS WITHIN 2 MINUTES: 31.1 MMOL/L (MOBILE SYSTEM 1) AND 7.5 MMOL/L (MOBILE SYSTEM 2). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701474 | ACCU-CHEK ® MOBILE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN |