FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® FLEXLINK INFUSION SET
MDR report key: 6084693
·
Received November 7, 2016
Report
- Report Number
- 3011393376-2016-07123
- Event Type
- Malfunction
- Date Received
- November 7, 2016
- Date of Event
- October 14, 2016
- Report Date
- December 1, 2016
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- FPA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
CUSTOMER STATED HE THINKS THERE IS SOMETHING DEFECTIVE WITH THE INFUSION SETS FROM HIS SUPPLIER. REPORTED THAT A FEW DAYS AGO WHEN HE CHANGED THE SITE, HE GAVE HIMSELF A BOLUS AND THE ADHESIVE WAS INSTANTLY WET. HE CHANGED THE SITE RIGHT AFTER HE NOTICED THE INSULIN SOAKING THE ADHESIVE PAD. HE DID NOT ALLEGE POOR ABSORPTION. NO ADVERSE EVENT ALLEGED. DEVICE NOT AVAILABLE FOR RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735589 | ACCU-CHEK ® FLEXLINK INFUSION SET | SUBCUTANEOUS INFUSION SET | FPA | ROCHE DIABETES CARE, INC. | 5139202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |