FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MOBILE TEST STRIPS
MDR report key: 3011470
·
Received March 19, 2013
Report
- Report Number
- 1823260-2013-01663
- Event Type
- Malfunction
- Date Received
- March 19, 2013
- Date of Event
- February 19, 2013
- Report Date
- May 3, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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.
Description of Event or Problem · 1
REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE MOBILE SYSTEM WITHIN 7 MINUTES: 14.7 MMOL/L AND 4.4 MMOL/L. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113780 | ACCU-CHEK ® MOBILE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 278180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 059 YR |