FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS
MDR report key: 2070416
·
Received April 19, 2011
Report
- Report Number
- 2183996-2011-01111
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 24, 2011
- Report Date
- March 24, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS, INC.
- Product Code
- FRN
- PMA / PMN Number
- K100704
- Removal / Correction Number
- Z-1487-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
ON (B)(6) 2011, THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF OVER 200 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 140-160 MG/DL. THE PATIENT IS VISUALLY IMPAIRED. SHE FELT THE INFUSION SET CANNULA AND COULD NOT DETERMINE IF IT WAS BENT. SHE STATED, THE INFUSION SITE WAS WET AND LEAKING INSULIN. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED PRODUCT WAS DISCARDED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK FLEXLINK PLUS | INSULIN INFUSION SET | FRN | ROCHE INSULIN DELIVERY SYSTEMS, INC. | NA | GWX190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | INSULIN| INSULIN INFUSION PUMP |