FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3921899
·
Received July 9, 2014
Report
- Report Number
- 1823260-2014-05010
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- June 15, 2014
- Report Date
- August 7, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SI
- 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 EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS OF 20-30 MMOL/L AND SHE PRESENTED POSITIVE KETONES. IT WAS OBSERVED THAT THE INFUSION DEVICE WENT INTO STOP-MODE THREE TIMES DURING THE DAY AND THE INFUSION DEVICE DID NOT DISPLAY AN ERROR OR ALERT MESSAGE BEFORE GOING INTO STOP-MODE. THE PATIENT SWITCHED TO ANOTHER INFUSION DEVICE AND HER BLOOD GLUCOSE LEVELS BEGAN TO STABILIZE. 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 |
|---|---|---|---|---|---|---|---|
| 401381 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 008 YR |