FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3894624
·
Received June 25, 2014
Report
- Report Number
- 1823260-2014-04655
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Date of Event
- March 2, 2014
- Report Date
- July 28, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- K111353
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CUSTOMER REPORTED THE BOLUS DELIVERY OF THE INFUSION DEVICE IS INACCURATE. SHE REPORTED THIS IS AN INTERMITTENT CONCERN, AND THE INFUSION DEVICE WILL STOP DELIVERING IN THE MIDDLE OF A BOLUS. WHEN THIS OCCURS, THE INFUSION DEVICE DOES NOT PROVIDE A WARNING/ERROR MESSAGE. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371044 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |