FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE
MDR report key: 4111581
·
Received September 23, 2014
Report
- Report Number
- 1823260-2014-07254
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Date of Event
- August 27, 2014
- Report Date
- October 13, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- K111353
- 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). DEVICE WAS DISCARDED.
Description of Event or Problem · 1
CALLER REPORTED THE PATIENT NOTICED THAT THE CARTRIDGE OF THE PUMP LEAKED OUT. CALLER STATED PATIENT'S BLOOD GLUCOSE READINGS ARE NORMAL. PATIENT DISPOSED OF THE CARTRIDGE. NO ADVERSE EVENT REPORTED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592322 | ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE | INSULIN INFUSION PUMP ACCESSORY | LZG | ROCHE DIAGNOSTICS | NA | 32062454 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 023 YR |