FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® TENDER INFUSION SET
MDR report key: 4112275
·
Received September 23, 2014
Report
- Report Number
- 1823260-2014-07257
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Date of Event
- August 14, 2014
- Report Date
- June 2, 2015
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FPA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
REPORTER STATED 5 INFUSION SETS FAILED AND THIS RESULTED IN HYPERGLYCEMIA. THE INFUSION TUBE SEPARATED FROM THE CANNULA, WHICH CAUSED INSULIN LEAKAGE AND AN INTERRUPTION IN INSULIN DELIVERY. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591683 | ACCU-CHEK ® TENDER INFUSION SET | SUBCUTANEOUS INFUSION SET | FPA | ROCHE DIAGNOSTICS | NA | 5053298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |