FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3961745
·
Received July 28, 2014
Report
- Report Number
- 1823260-2014-05595
- Event Type
- Malfunction
- Date Received
- July 28, 2014
- Date of Event
- July 3, 2014
- Report Date
- August 25, 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
IT WAS REPORTED THAT THE PATIENT ALLEGES THAT THE INFUSION DEVICE WAS DELIVERING TOO LOW AN AMOUNT OF INSULIN. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS AS HIGH AS 500 MG/DL. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439356 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |