FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 1934368
·
Received December 3, 2010
Report
- Report Number
- 2183996-2010-02557
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Date of Event
- November 26, 2010
- Report Date
- December 1, 2010
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC
- Product Code
- LZG
- PMA / PMN Number
- K060876
- Removal / Correction Number
- Z-1415-2009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2010, MOTHER REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE WAS NOT FUNCTIONING PROPERLY. PT HAD THE INFUSION DEVICE WITH HIM, AND MOTHER COULD NOT COMPLETE TROUBLESHOOTING. PT NOTICED THE DOWN BUTTON WAS DEFECTIVE WHEN HE ATTEMPTED TO BOLUS. HE HAS USED THIS INFUSION DEVICE FOR 3-4 YEARS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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 | 15 YR | INSULIN INFUSION SET| INSULIN |