FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MOBILE TEST STRIPS
MDR report key: 2991279
·
Received March 6, 2013
Report
- Report Number
- 1823260-2013-01337
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Date of Event
- February 11, 2013
- Report Date
- March 6, 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. THIS MEDWATCH IS FOR THE MOBILE SYSTEM. REFERENCE MEDWATCH WITH (B)(6) FOR THE COMPACT PLUS SYSTEM.
Description of Event or Problem · 1
REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON TWO DIFFERENT METERS WITHIN 1 MINUTE: 112 MG/DL (MOBILE) AND 62 MG/DL (COMPACT PLUS). 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 |
|---|---|---|---|---|---|---|---|
| 95367 | ACCU-CHEK ® MOBILE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 278175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 076 YR |