FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MOBILE TEST STRIPS
MDR report key: 3191477
·
Received June 26, 2013
Report
- Report Number
- 1823260-2013-03892
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- June 3, 2013
- Report Date
- August 28, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE MOBILE SYSTEM WITHIN 1 MINUTE: 22.1 MMOL/L, 16.8 MMOL/L AND 10.0 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 |
|---|---|---|---|---|---|---|---|
| 290025 | ACCU-CHEK ® MOBILE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 278192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 063 YR | UNSPECIFIED HEART MEDICATION| NOVORAPID| UNSPECIFIED CHOLESTEROL MEDICATION| DIABETA| LANTUS| UNSPECIFIED BLOOD PRESSURE MEDICATION| UNSPECIFIED ANTIBIOTIC |