FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ULTRAFLEX INFUSION SET
MDR report key: 1890032
·
Received November 1, 2010
Report
- Report Number
- 2183996-2010-02203
- Event Type
- Injury
- Date Received
- November 1, 2010
- Date of Event
- October 25, 2010
- Report Date
- October 25, 2010
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- FPA
- PMA / PMN Number
- K070189
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2010, PT REPORTED WHILE PRIMING THE INFUSION TUBING, SHE NOTICED A LEAK AT THE CONNECTION TO THE LUER LOCK. PT STATED THAT EXPLAINS WHY HER READINGS WERE ELEVATED THIS AFTERNOON. PT REPORTED HER METER JUST REGISTERED 'HI'. PT'S TARGET BLOOD GLUCOSE RANGE IS 80-120 MG/DL. PT STATED SHE TREATED HER HIGHS WITH AN INJECTION OF INSULIN. PT REPORTED THE INFUSION TUBING WAS LAST CHANGED 3 DAYS AGO AND IT WAS TIME FOR HER TO CHANGE IT TODAY ANYWAY. PT IS USING LITHIUM BATTERIES. ADVISED PT TO USE ALKALINE OR RECHARGABLE BATTERIES. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ULTRAFLEX INFUSION SET | INSULIN INFUSION SET | FPA | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | 9C128UF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | INSULIN| INSULIN INFUSION PUMP |