FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ULTRAFLEX INFUSION SET
MDR report key: 1051272
·
Received May 22, 2008
Report
- Report Number
- 2183996-2008-00752
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 28, 2008
- Report Date
- May 19, 2008
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- Product Code
- FPA
- PMA / PMN Number
- K070189
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WILL BE RETURNED FOR EVAL.
Description of Event or Problem · 1
IN 2008, THE PT REPORTED THAT BECAUSE THE WEATHER IS GETTING WARMER HE IS HAVING ISSUES WITH THE ADHESIVE OF HIS INFUSION SETS STICKING TO HIS BODY. HE STATED THAT HE WORKS OUTSIDE AND HAS TO CHANGE THE INFUSION SITES MORE OFTEN DUE TO THE MOISTURE. HE STATED THAT HE USES IV PREP WIPES BEFORE INSERTING THE INFUSION SITE. HE WAS SENT SAMPLES OF TEGADERM HP DRESSING AND ADVISED OF THE "SANDWICH METHOD." UPON FOLLOW UP ON FOUR DAYS LATER, THE PT STATED HE USED THE TEGADERM HP AND IT IS WORKING WELL FOR HIM. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ULTRAFLEX INFUSION SET | INSULIN INFUSION SET | FPA | DISETRONIC MEDICAL SYSTEMS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN INFUSION PUMP| INSULIN |