FDA Adverse Event
Malfunction
Summary report: N
ULTRAFLEX INFUSION SET
MDR report key: 765490
·
Received August 4, 2006
Report
- Report Number
- 2183996-2006-00633
- Event Type
- Malfunction
- Date Received
- August 4, 2006
- Date of Event
- July 24, 2006
- Report Date
- July 24, 2006
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS, INC.
- Product Code
- FPA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PT REPORTED THAT HER ACCU-CHEK ULTRAFLEX INFUSION SETS ARE BEING PACKAGED WITH THE DISETRONIC HEAD SETS AND THE ACCU-CHEK ULTRAFLEX TUBING. THE TWO PIECES ARE NOT COMPATABLE AND WILL NOT "SNAP" TOGETHER WHEN TRYING TO CONNECT. THE PT DID NOT SUFFER ANY PHYSIOLOGICAL EFFECTS DUE TO THIS ISSUE. NO MEDICAL TREATMENT WAS REQUIRED. PRODUCT WAS REQUESTED TO BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRAFLEX INFUSION SET | INSULIN INFUSION SET | FPA | DISETRONIC MEDICAL SYSTEMS, INC. | ULTRAFLEX | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | DATE OF TREATMENT: NA| INSULIN, INSULIN INFUSION PUMP |