FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1821752
·
Received August 25, 2010
Report
- Report Number
- 2531779-2010-01089
- Event Type
- Malfunction
- Date Received
- August 25, 2010
- Date of Event
- July 27, 2010
- Report Date
- July 27, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Removal / Correction Number
- 2531779-03/24/2010-003-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP RETURNED TO ANIMAS. EVALUATION REVEALED THAT THE FORCE SENSOR RESISTANCE READING WAS OUT OF CALIBRATION. EVALUATION ALSO REVEALED VISIBLE MOISTURE INGRESS ON THE FORCE SENSOR AND DETERMINED THAT THE MOISTURE IMPACTED THE FORCE SENSOR RESISTANCE. REVIEW OF THE PUMP HISTORY REVEALED A LOSS OF PRIME WARNING ASSOCIATED WITH ZERO FORCE AND A "NO CARTRIDGE DETECTED" WARNING. THE PUMP DID NOT DETECT THE CARTRIDGE ON THE LOAD STEP DURING EVALUATION AND DISPENSED INSULIN FROM THE CARTRIDGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP DISPENSED INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |