FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT CARTRIDGE
MDR report key: 1821274
·
Received August 26, 2010
Report
- Report Number
- 2183996-2010-01683
- Event Type
- Malfunction
- Date Received
- August 26, 2010
- Date of Event
- May 17, 2010
- Report Date
- August 13, 2010
- 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
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
PATIENT REPORTED THE INSULIN CARTRIDGES FROM THIS BOX ARE LEAKY DURING USE. PATIENT STATED INSULIN FLOWS OUT BETWEEN THE CARTRIDGE PLUNGER AND THE CARTRIDGE INSIDE. PATIENT REPORTED THE CARTRIDGE PLUNGER OFTEN GETS STUCK ON THE PISTON ROD OF THE INFUSION DEVICE. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT CARTRIDGE | INSULIN INFUSION PUMP CARTRIDGE | LZG | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | 32386359 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN| INSULIN INFUSION SET |