FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE
MDR report key: 4091537
·
Received September 16, 2014
Report
- Report Number
- 1823260-2014-07019
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- June 18, 2014
- Report Date
- October 16, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- K111353
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- 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 DURING THE PAST COUPLE OF MONTHS THERE HAS BEEN CONDENSATION IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE PATIENT IS NOT CERTAIN WHETHER THE CONDENSATION IS DUE TO INSULIN LEAKING FROM THE INSULIN CARTRIDGE OR IF THE CONDENSATION IS WATER. THE INSULIN CARTRIDGES WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION. NO ADVERSE EVENT WAS REPORTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571820 | ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE | INSULIN INFUSION PUMP ACCESSORY | LZG | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |