FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 2833963
·
Received November 9, 2012
Report
- Report Number
- 2183996-2011-03154
- Event Type
- Malfunction
- Date Received
- November 9, 2012
- Date of Event
- March 11, 2011
- Report Date
- March 11, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEM INC.
- Product Code
- LZG
- PMA / PMN Number
- K060876
- Removal / Correction Number
- Z-1646-2009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE UP/DOWN BUTTON DOES NOT OPERATE. THE PRINTED CIRCUIT OF THE UP/DOWN FLEX CONNECTION IS INTERRUPTED.
Description of Event or Problem · 1
THE PATIENT CALLED DUE TO AN UNCLEARABLE E10 (CARTRIDGE) ERROR. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE INSULIN INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION. EVALUATION OF THE DEVICE FOUND THAT THE UP/DOWN BUTTON WAS DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT | LZG | ROCHE INSULIN DELIVERY SYSTEM INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | INSULIN INFUSION PUMP| INSULIN| DATE OF THERAPY: UNK| RELATED ACCESSORIES |