FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS
MDR report key: 2081483
·
Received April 12, 2011
Report
- Report Number
- 2183996-2011-00976
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- November 1, 2010
- Report Date
- March 14, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z-1486-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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. NO PRODUCT WILL BE RETURNED FOR EVAL.
Description of Event or Problem · 1
THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 27 MMOL/L (486 MG/DL) WHILE USING THE INFUSION SETS. SHE ALSO REPORTED SOME HEADSET CANNULAS WERE KINKED AND THE ADHESIVE DID NOT STICK WELL AND LEFT A RED MARK ON HER SKIN. SHE NOTICED THE ISSUE WITHIN AN HOUR OF USE. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT IS AVAILABLE TO BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK FLEXLINK PLUS | INSULIN INFUSION PUMP | LZG | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | GWX188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN INFUSION PUMP| INSULIN |