FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
MDR report key: 2981386
·
Received February 27, 2013
Report
- Report Number
- 1823260-2013-01201
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 4, 2013
- Report Date
- March 25, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER STATES THAT A PATIENT REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE INFORM SYSTEM WITHIN 10 MINUTES: 416 MG/DL AND 110 MG/DL. PATIENT WAS TREATED BASED UPON THE READING OF 110 MG/DL (TREATMENT NOT PROVIDED). NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85400 | ACCU-CHEK ® COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 551863 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 054 YR | CELEXA 1X DAILY| METOPROLOL 2X DAILY| NORCO| PRILOSEC 1X DAILY| COLACE 2X DAILY| HUMALOG| HYDROCORTISONE 2X DAILY| LANTUS 1X NIGHTLY| TRAZODONE 1X NIGHTLY| NORVASC 1X DAILY| BACLOFEN 2X DAILY| CALCIUM PLUS VITAMIN D-3 3X DAILY| TYLENOL 6X DAILY| FLOMAX 1X NIGHTLY |