FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 5795586
·
Received July 14, 2016
Report
- Report Number
- 3011393376-2016-04673
- Event Type
- Malfunction
- Date Received
- July 14, 2016
- Date of Event
- June 7, 2016
- Report Date
- October 14, 2016
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- LZG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED OUTSIDE THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
CUSTOMER ASSUMES THAT THE PUMP DELIVERS INCORRECTLY BECAUSE FOR 14 DAYS, SHE HAS HAD HIGH BLOOD GLUCOSE LEVELS (16 MMOL/L - 22 MMOL/L). NO ADVERSE EVENT ALLEGED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448636 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIABETES CARE, INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |