FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3970220
·
Received July 31, 2014
Report
- Report Number
- 1823260-2014-05735
- Event Type
- Injury
- Date Received
- July 31, 2014
- Date of Event
- July 11, 2014
- Report Date
- October 2, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INFUSION DEVICE DISPLAYED E2 (BATTERY EMPTY) WHEN ATTEMPTING TO DELIVER A BOLUS ON MULTIPLE OCCASIONS. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS AS HIGH AS 568 MG/DL. HE WAS TAKEN TO THE EMERGENCY ROOM FOR THREE DAYS IN A ROW WHERE HE RECEIVED INSULIN VIA IV AND INJECTIONS. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447056 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 014 YR | Hospitalization| R |