FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE
MDR report key: 6156146
·
Received December 8, 2016
Report
- Report Number
- 3011393376-2016-07716
- Event Type
- Malfunction
- Date Received
- December 8, 2016
- Date of Event
- November 7, 2016
- Report Date
- March 3, 2017
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- LZG
- PMA / PMN Number
- K111353
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CUSTOMER IS CALLING TO REPORT THAT HE HAS NOTICED CONDENSATION IN THE CARTRIDGE COMPARTMENT. IT ALWAYS SHOWED UP ABOUT HALFWAY THROUGH A CARTRIDGE AND DID SMELL LIKE INSULIN. HE THOUGHT MAYBE THE CARTRIDGES WERE LEAKING. NO ADVERSE EVENT ALLEGED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 805439 | ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE | INSULIN INFUSION PUMP ACCESSORY | LZG | ROCHE DIABETES CARE, INC. | 32396235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |