FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3790145
·
Received May 5, 2014
Report
- Report Number
- 1823260-2014-03178
- Event Type
- Malfunction
- Date Received
- May 5, 2014
- Date of Event
- March 9, 2014
- Report Date
- July 25, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- K111353
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Additional Manufacturer Narrative · 1
CORRECTION, THE SERIAL NUMBER IS (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2014, THE PATIENT REPORTED THAT IN THE NIGHT HER INFUSION DEVICE DISPLAYED E4 (OCCLUSION ERROR). SHE STATED THAT THE INSULIN CARTRIDGE COMPARTMENT WAS WET WITH INSULIN. SHE STATED THIS HAS HAPPENED EIGHT TIMES. SHE CANNOT TELL FROM WHERE THE INSULIN IS LEAKING. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE, INSULIN CARTRIDGE, ADAPTER, AND INFUSION SET WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267527 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 078 YR | MAGNESIUM SULFATE| NEXIUM| AMITRIPTYLINE| BUMEX| CILIUM HUSK| XANEX| CANE| POTASSIUM CHLORIDE| NOVOLOG| BYETTA| CYMBALTA |