FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® TENDER INFUSION SET
MDR report key: 4173765
·
Received October 15, 2014
Report
- Report Number
- 1823260-2014-07934
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 16, 2014
- Report Date
- February 13, 2015
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FPA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
CALLER REPORTED THE CONNECTOR WAS SEPARATED FROM THE TUBE OF THE PUMP. CALLER STATED THERE WAS A LEAK WHEN THE TUBE SEPARATED FROM THE CONNECTOR. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 656026 | ACCU-CHEK ® TENDER INFUSION SET | SUBCUTANEOUS INFUSION SET | FPA | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 053 YR |