ACCU-CHEK SPIRIT CARTRIDGE
Report
- Report Number
- 2183996-2011-00115
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 6, 2011
- Report Date
- January 20, 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
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
NO PRODUCT WILL BE RETURNED FOR EVAL.
ON (B)(6) 2011, PT REPORTED HE HAD MOISTURE IN HIS INFUSION DEVICE CARTRIDGE COMPARTMENT AND BELIEVES THAT LED TO AN ELEVATED BLOOD GLUCOSE. PT REPORTED HIS BLOOD GLUCOSE LEVEL WAS IN THE 400'S MG/DL. PT STATED HE WAS ABLE TO TREAT HIMSELF AND BRING HIS BLOOD GLUCOSE BACK DOWN TO HIS NORMAL RANGE OF 95-160 MG/DL. PATIENT REPORTED THE INSULIN CARTRIDGE WAS IN USE FOR 10 DAYS TO TWO WEEKS. ADVISED TO USE A HALF OF THE INSULIN CARTRIDGE. ADVISED TO USE EACH CARTRIDGE FOR A MAXIMUM OF 6 DAYS. PT STATED HE HAS NEVER CHANGED THE INFUSION ADAPTER. ADVISED TO CHANGE THE ADAPTER EVERY 10TH CARTRIDGE CHANGE. PT REPORTED THERE WAS NOT A LOT OF MOISTURE IN THE CARTRIDGE; WAS ABLE TO CLEAN THE COMPARTMENT OUT. PATIENT STATED HE DOES NOT LET INSULIN WARM TO ROOM TEMPERATURE. ADVISED OF PROPER USAGE OF INSULIN AND CARTRIDGE. PT REPORTED THE INSULIN CARTRIDGE WAS DISCARDED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT RETURN WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT CARTRIDGE | INSULIN INFUSION PUMP CARTRIDGE | LZG | ROCHE INSULIN DELIVERY SYSTEMS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | INSULIN INFUSION SET| INSULIN |