FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3962714
·
Received July 29, 2014
Report
- Report Number
- 1823260-2014-05612
- Event Type
- Malfunction
- Date Received
- July 29, 2014
- Date of Event
- July 4, 2014
- Report Date
- August 20, 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
PATIENT REPORTED EXPERIENCING 3 OR 4 EPISODES OF ELEVATED BLOOD GLUCOSE LEVELS. PATIENT STATED SHE WOKE UP THIS MORNING AND HAD A BLOOD GLUCOSE READING OF 400 MG/DL, TOOK A BOLUS, HER LEVEL DECREASED, AND SHE WENT TO WORK. PATIENT REPORTED THAT LATER, SHE CHECKED THE PUMP AND NOTICED AIR BUBBLES IN THE CARTRIDGE. PATIENT REPORTED SHE THINKS THE PUMP COULD HAVE A PROBLEM WITH DELIVERY INACCURACY BECAUSE SHE CANNOT EXPLAIN THE ELEVATED LEVELS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440877 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |