FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT PLUS TEST DRUM
MDR report key: 3895269
·
Received June 25, 2014
Report
- Report Number
- 1823260-2014-04673
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Date of Event
- May 30, 2014
- Report Date
- June 25, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K031755
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED RESULTS OF 17 MG/DL AND 73 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. CUSTOMER DRANK ORANGE JUICE UPON RECEIVING THE RESULT OF 73 MG/DL. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, THE TEST STRIP VIAL WAS DISCARDED. REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371156 | ACCU-CHEK ® COMPACT PLUS TEST DRUM | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 071 YR | SIMVASTATIN| NOVOLOG| FLOMAX |