FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 4192354
·
Received October 22, 2014
Report
- Report Number
- 1823260-2014-08139
- Event Type
- Injury
- Date Received
- October 22, 2014
- Date of Event
- September 20, 2014
- Report Date
- October 30, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 IN (B)(6). 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
ON (B)(6) 2014, THE CUSTOMER HAD LOW BG LEVEL (30 MG/DL). ON (B)(6) 2014, SHE REQUIRED TREATMENT OF DEXTROSE FROM HER FAMILY. CUSTOMER THINKS THAT THE PUMP DELIVERS TOO MUCH INSULIN. NO OTHER INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673920 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 046 YR | Required Intervention | INSUMAN INFUSAT |