FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE
MDR report key: 4220988
·
Received November 3, 2014
Report
- Report Number
- 1823260-2014-08461
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- October 4, 2014
- Report Date
- December 19, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- K043000
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.
Description of Event or Problem · 1
CUSTOMER'S SCHOOL NURSE REPORTED SEEING CONDENSATION IN THE CARTRIDGE COMPARTMENT. NURSE STATED CUSTOMER NOTICED THE ISSUE ON SATURDAY AND CHANGED THE CARTRIDGE. NURSE REPORTED CUSTOMER ALSO NOTICED THE CONDENSATION THIS MORNING PRIOR TO GOING TO SCHOOL AND CHANGED THE CARTRIDGE THIS MORNING; ISSUE PERSISTS. NURSE STATED THE LEAK IS FORM THE BOTTOM OF THE CARTRIDGE. CUSTOMER IS NEW TO PUMP THERAPY. CUSTOMER'S MOTHER REPORTED THEY WORKED WITH THE TRAINER LAST NIGHT AND THEY CONTINUED TO HAVE THE LEAKAGE FROM THE BOTTOM OF THE CARTRIDGE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703028 | ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE | INSULIN INFUSION PUMP ACCESSORY | LZG | ROCHE DIAGNOSTICS | NA | 32162374 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |