FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT TEST DRUM
MDR report key: 2010079
·
Received March 8, 2011
Report
- Report Number
- 1823260-2011-01209
- Event Type
- Malfunction
- Date Received
- March 8, 2011
- Date of Event
- February 17, 2011
- Report Date
- April 18, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K031755
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTED COMPACT PLUS RESULT OF 295-300 MG/DL, PROFESSIONAL RESULT OF 135 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® COMPACT TEST DRUM | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 20728445 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 047 YR | LISINOPRIL| ALENDRONATE| HYRDOCORDOZONE| FENOFIBRATE| MUCINEX| SPIRIVA| ADVAIR| APNEA MONITOR| RANITIDINE| SPIRONOLACTONE| VITAMIN D-2| LEVOTHYROXINE |