FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 2172363
·
Received June 17, 2011
Report
- Report Number
- 2183996-2011-01757
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 25, 2011
- 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
- NJ, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2011, PATIENT REPORTED THE AUDIO-SIGNAL ON THE INFUSION DEVICE IS DEFECTIVE. THE INFUSION DEVICE DISPLAYED A1 CARTRIDGE LOW, A2 LOW BATTERY, AND E2 BATTERY DEPLETED ERRORS AND SHE DID NOT HEAR THE INFUSION DEVICE ALARM. THE ALARMS WERE VERIFIED BY VIEWING THE INFUSION DEVICE HISTORY. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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 | 50 YR | INSULIN| INSULIN INFUSION SET |