ACCU-CHECK SPIRIT
Report
- Report Number
- 2183996-2010-01095
- Event Type
- Malfunction
- Date Received
- May 26, 2010
- Date of Event
- April 22, 2010
- Report Date
- April 28, 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
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
NO PRODUCT WILL BE RETURNED FOR EVAL.
ON (B)(6) 2010, THE PT REPORTED THE INFUSION DEVICE GOES INTO STOP MODE WITHOUT WARNING. HE STATED THAT LAST NIGHT HE ATE DINNER AND HIS BLOOD GLUCOSE WAS ELEVATED DUE TO WHAT HE HAD EATEN (VALUE NOT PROVIDED). HIS NORMAL BLOOD GLUCOSE RANGE IS 130-140 MG/DL. HE STATED THAT BEFORE LEAVING FOR WORK HE CHECKED THE INFUSION DEVICE AND THE HOURLY BASAL RATE WAS DISPLAYED ON THE SCREEN. WHEN HE ARRIVED AT WORK, THE INFUSION DEVICE WAS IN THE STOP MODE. HE STATED, HE HAD NOT PRESSED ANY BUTTONS AND THE AUTOMATIC OFF WAS NOT PROGRAMMED. HE STATED THAT HE HAD RECEIVED AN E4 (OCCLUSION) ERROR EARLIER AND HE HAD PLACED THE INFUSION DEVICE BACK IN THE RUN MODE AFTER CLEARING THE ERROR. HE DECLINED TO HAVE THE INFUSION DEVICE REPLACED STATING HE MAY HAVE CAUSED THE ISSUE TO OCCUR. NO PHYSIOLOGICAL EFFECTS RELATED TO THE INFUSION DEVICE GOING INTO THE STOP MODE WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHECK SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | INSULIN| INSULIN INFUSION SET |