FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO ADAPTER
MDR report key: 4200285
·
Received October 24, 2014
Report
- Report Number
- 1823260-2014-08250
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Date of Event
- October 12, 2014
- Report Date
- October 24, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- K111353
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
CUSTOMER REPORTED A SMALL AMOUNT OF INSULIN LEAKED INTO THE INFUSION DEVICE AFTER THE ADAPTER CAME LOOSE. NO ADVERSE EVENT WAS REPORTED. THE ADAPTER AND CARTRIDGE HAVE BEEN DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679832 | ACCU-CHEK ® SPIRIT COMBO ADAPTER | INSULIN INFUSION PUMP ACCESSORY | LZG | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |