FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 2070360
·
Received April 18, 2011
Report
- Report Number
- 2183996-2011-01097
- Event Type
- Malfunction
- Date Received
- April 18, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 23, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LO
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
PT REPORTED AN E8 POWER INTERRUPT ERROR APPEARED DURING NORMAL OPERATION OF THE INFUSION DEVICE, AND THE ERROR MESSAGE COULD NOT BE CLEARED DUE TO UNRESPONSIVE BUTTONS. PT CHANGED THE BATTERY AND WAITED 2 HOURS, BUT THIS DID NOT RESOLVE THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADD'L INFO WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN| INSULIN INFUSION SET |