FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® TENDER INFUSION SET
MDR report key: 3874872
·
Received June 16, 2014
Report
- Report Number
- 1823260-2014-04381
- Event Type
- Malfunction
- Date Received
- June 16, 2014
- Date of Event
- May 12, 2014
- Report Date
- July 16, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FPA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S INFUSION SET WAS LEAKING INSULIN BETWEEN THE HEADSET AND THE CANNULA. THE PATIENT EXPERIENCED AN ELEVATED BLOOD GLUCOSE LEVEL OF 300 MG/DL. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352162 | ACCU-CHEK ® TENDER INFUSION SET | SUBCUTANEOUS INFUSION SET | FPA | ROCHE DIAGNOSTICS | NA | 5044356 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |