FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 1821841
·
Received August 26, 2010
Report
- Report Number
- 2183996-2010-01726
- Event Type
- Malfunction
- Date Received
- August 26, 2010
- Date of Event
- July 21, 2010
- Report Date
- August 11, 2010
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- LZG
- PMA / PMN Number
- K060876
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2010, PATIENT REPORTED THE DOWN BUTTON ON HER INFUSION DEVICE WAS NOT WORKING PROPERLY. THIS WAS NOTICED A COUPLE OF WEEKS PRIOR; PATIENT REPORTED SHE DOES NOT BOLUS EVERYBODY SO SHE FORGOT ABOUT IT. PATIENT HAS USED THIS INFUSION DEVICE FOR SEVERAL YEARS. DOWN BUTTON POPS UP AFTER BEING PRESSED. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER. UP BUTTON CONTINUES TO FUNCTION AS INTENDED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.
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 | 60 YR | INSULIN| INFUSION SET |