FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 4230064
·
Received November 6, 2014
Report
- Report Number
- 1823260-2014-08613
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- October 9, 2014
- Report Date
- December 2, 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 INFUSION DEVICE DISPLAYED 0.6 I.U. AND THEN DELIVERED THAT AMOUNT WITHOUT PROGRAMMING BY THE CUSTOMER. THE CUSTOMER WAS UNABLE TO CANCEL THE BOLUS BY PRESSING THE BUTTONS ON THE INFUSION DEVICE. HE CHANGED THE BATTERY BUT THE SAME ISSUE OCCURRED AT A LATER TIME. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715832 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 057 YR |