FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 4212914
·
Received October 30, 2014
Report
- Report Number
- 1823260-2014-08388
- Event Type
- Malfunction
- Date Received
- October 30, 2014
- Date of Event
- October 5, 2014
- Report Date
- December 3, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- NA
- 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 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
REPORTER STATED THE CUSTOMER HAS EXPERIENCED HYPERGLYCEMIA OF UP TO 485 MG/DL, AND SHE BELIEVES THE PISTON ROD DOES NOT MOVE CORRECTLY AND THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. SHE DELIVERED INSULIN VIA PEN AND THE INFUSION DEVICE AS TREATMENT, AND NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695557 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 032 YR | UNSPECIFIED TYPE OF INSULIN |