FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3971166
·
Received July 31, 2014
Report
- Report Number
- 1823260-2014-05756
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Date of Event
- July 14, 2014
- Report Date
- October 27, 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).
Description of Event or Problem · 1
REPORTER STATED ON TWO OCCASIONS THE INFUSION DEVICE DISPLAYED AN E4 OCCLUSION ERROR BUT DID NOT PROVIDE AN ACOUSTIC OR VIBRATION ALERT. DURING THE FIRST EVENT, THE CUSTOMER EXPERIENCED HYPERGLYCEMIA OF UP TO 508 MG/DL DESPITE DELIVERING INSULIN VIA THE INFUSION DEVICE. THE CUSTOMER'S MOTHER CHECKED THE INFUSION DEVICE AND NOTICED THE E4 ERROR ON THE DISPLAY. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447933 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 018 MO |