FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® ULTRAFLEX INFUSION SET
MDR report key: 3871294
·
Received June 13, 2014
Report
- Report Number
- 1823260-2014-04315
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- May 16, 2014
- Report Date
- July 24, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FPA
- PMA / PMN Number
- K101196
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CUSTOMER REPORTED SHE EXPERIENCED HYPERGLYCEMIA DUE TO A LEAK IN THE INFUSION SET. HER BLOOD GLUCOSE WAS IN THE 400 MG/DL RANGE, AND SHE DELIVERED A BOLUS. SHE DETECTED MOISTURE AROUND HER INSERTION SITE AND REMOVED THE INFUSION SET. SHE FOUND THE CANNULA WAS BENT AGAINST THE OUTSIDE OF THE SKIN. SHE DELIVERED AN INSULIN INJECTION AS TREATMENT. THE INFUSION SET WAS REQUESTED FOR EVALUATION. NO ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351139 | ACCU-CHEK ® ULTRAFLEX INFUSION SET | SUBCUTANEOUS INFUSION SET | FPA | ROCHE DIAGNOSTICS | NA | 5046632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 067 YR |