FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3944711
·
Received July 18, 2014
Report
- Report Number
- 1823260-2014-05378
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 26, 2014
- Report Date
- July 31, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
REPORTER STATED THE CUSTOMER EXPERIENCED HYPERGLYCEMIA OF 15.0-16.0 MMOL/L, AND SHE BELIEVES THE INFUSION DEVICE DOES NOT CORRECTLY DELIVER BASAL RATES. SHE DELIVERED INSULIN VIA PEN AND THEN SWITCHED TO A LOANER INFUSION DEVICE, AND SHE HAS EXPERIENCED NO FURTHER PROBLEMS. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422882 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 052 YR |