FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3052065
·
Received April 11, 2013
Report
- Report Number
- 2183996-2013-00645
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- April 8, 2013
- Report Date
- May 22, 2013
- Manufacturer
- ROCHE DIABETES CARE AG
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. THE SOFT COMPONENT OF THE UP BUTTON IS LACERATED, AND THE DAMAGE DID NOT INFLUENCE THE INSULIN PUMP FUNCTIONS. THE BUTTON FUNCTION WAS TESTED SUCCESSFULLY AND COMPLIES WITH THE SPECIFICATIONS.
Additional Manufacturer Narrative · 1
THE 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 BUTTONS ON THE INFUSION DEVICE WORK INTERMITTENTLY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155373 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIABETES CARE AG | 00700006863 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 041 YR |