FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ULTRAFLEX
MDR report key: 2971687
·
Received January 30, 2013
Report
- Report Number
- 2183996-2013-00133
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- January 5, 2013
- Report Date
- March 12, 2013
- Manufacturer
- ROCHE HEALTH SOLUTIONS INC.
- Product Code
- FPA
- PMA / PMN Number
- K101196
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR OCCLUSION AND TIGHTNESS. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED. PRODUCT NOT RETURNED.
Description of Event or Problem · 1
ON (B)(6) 2013, THE PT REPORTED THAT SHE HAS HAD INSULIN LEAK AT HER INFUSION SITE. THE PT STATED THAT THE LEAK IS COMING FROM THE CANNULA. SHE NOTICES THE LEAK WHEN HER SHIRT BECOMES WET WITH INSULIN. WHEN SHE REMOVES THE CANNULA IT IS BENT. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SETS WERE DISCARDED, THEREFORE, NO PRODUCT WAS REQUESTED TO BE RETURNED FOR PRODUCT EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41831 | ACCU-CHEK ULTRAFLEX | FPA | ROCHE HEALTH SOLUTIONS INC. | NA | 0234017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP |