FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 2943086
·
Received January 18, 2013
Report
- Report Number
- 2183996-2012-02159
- Event Type
- Malfunction
- Date Received
- January 18, 2013
- Date of Event
- October 8, 2012
- Report Date
- October 8, 2012
- Manufacturer
- ROCHE HEALTH SOLUTIONS INC
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z-1646-2009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PT REPORTED AN ISSUE WITH THE UP/DOWN BUTTON OF THE INFUSION DEVICE. NO SERIOUS INJURY WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVAL. EVAL OF THE DEVICE FOUND THAT THE UP/DOWN BUTTON WAS DEFECTIVE. DURING A TELECONFERENCE ((B)(4) 2012) WITH PERSONNEL FROM THE (B)(4), A REQUEST WAS MADE TO SUBMIT MEDWATCH REPORTS FOR ALL OUS COMPLAINTS RELATED TO THE ACCU-CHEK SPIRIT RECALL (Z-1646-2009) RECEIVED AFTER CLOSURE OF THE RECALL ON 07/03/2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28357 | ACCU-CHEK SPIRIT | LZG | ROCHE HEALTH SOLUTIONS INC | 00700006862 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES |