FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3981304
·
Received August 5, 2014
Report
- Report Number
- 1823260-2014-05891
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- July 29, 2014
- Report Date
- September 15, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
REPORTER STATED THE INFUSION DEVICE DOES NOT DELIVER INSULIN CORRECTLY. THE CUSTOMER'S BLOOD GLUCOSE ELEVATED TO 450 MG/DL, AND HE CHANGED THE INFUSION SET AND CARTRIDGE BUT THE PISTON ROD WOULD NOT MOVE FORWARD. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457781 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |