FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 2172402
·
Received June 17, 2011
Report
- Report Number
- 2183996-2011-01691
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- April 5, 2011
- Report Date
- May 23, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
PATIENT REPORTED, THERE WERE BLACK LINES ON THE INFUSION DEVICE DISPLAY, BUT ALL NUMBERS AND LETTERS WERE VISIBLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND RETURNED FOR EVALUATION. THE COMPLAINT CAN BE VERIFIED. THE INFUSION DEVICE DISPLAY IS MISSING A PIXEL COLUMN DUE TO AN INTERRUPTION OF THE HEAT-SEAL CONNECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN| INSULIN INFUSION SET |