FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 2861505
·
Received November 28, 2012
Report
- Report Number
- 2183996-2012-01816
- Event Type
- Malfunction
- Date Received
- November 28, 2012
- Date of Event
- November 15, 2012
- Report Date
- November 15, 2012
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- LZG
- PMA / PMN Number
- K060876
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ON (B)(6) 2012 THE PT REPORTED THAT E1 (CARTRIDGE DEPLETED) ERROR WAS DISPLAYED ON THE INFUSION DEVICE AND HE DOES NOT RECALL RECEIVING THE A1 (CARTRIDGE LOW) ALERT. HE WAS ASSISTED IN CHANGING THE INSULIN CARTRIDGE. THE PT REVIEWED THE DEVICE ALARM HISTORY AND NO A1 WAS LISTED. HE STATED THAT THE INSULIN CARTRIDGES ARE FULL WHEN INSERTED INTO THE INFUSION DEVICE AND HE PROPERLY ADJUSTS THE PISTON ROD. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED. THE INFUSION DEVICE, BATTERY, AND BATTERY COVER WERE REQUESTED TO BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT | LZG | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES |