FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3952460
·
Received July 23, 2014
Report
- Report Number
- 1823260-2014-05443
- Event Type
- Injury
- Date Received
- July 23, 2014
- Date of Event
- June 24, 2014
- Report Date
- September 12, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- 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 DROPPED HER INFUSION DEVICE ON A STONE AND THE DISPLAY BROKE MAKING IT UNREADABLE. THE PATIENT ATTEMPTED TO CONTINUED USING THE DEVICE WITH AN UNREADABLE DISPLAY AND WAS UNSUCCESSFUL IN LOWERING ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF REPORT. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430396 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |