FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MOBILE TEST STRIPS
MDR report key: 3162613
·
Received June 11, 2013
Report
- Report Number
- 1823260-2013-03491
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Date of Event
- May 6, 2013
- Report Date
- June 11, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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. WILL NOT BE RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED RESULTS OF 423 MG/DL AND 163 MG/DL WITHIN 10 MINUTES ON THE MOBILE SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CUSTOMER NO LONGER HAS THE TEST CASSETTE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263356 | ACCU-CHEK ® MOBILE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 278222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 062 YR |