FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT PLUS TEST DRUM
MDR report key: 4110879
·
Received September 23, 2014
Report
- Report Number
- 1823260-2014-07244
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Date of Event
- August 21, 2014
- Report Date
- November 13, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K113614
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
WILL NOT BE RETURNED TO MANUFACTURER.
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 SYSTEM BLOOD GLUCOSE RESULTS OF 153 MG/DL AND 82 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 |
|---|---|---|---|---|---|---|---|
| 592246 | ACCU-CHEK ® COMPACT PLUS TEST DRUM | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 080 YR | NOVOLOG| LEVEMIR| INHALER |