FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS
MDR report key: 2081685
·
Received April 13, 2011
Report
- Report Number
- 2183996-2011-00965
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 17, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS, INC.
- Product Code
- FRN
- PMA / PMN Number
- K100704
- Removal / Correction Number
- Z-1492-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 350 MG/DL WHILE USING THE INFUSION SETS. HER NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. SHE BOLUSED AND PROGRAMMED A TEMPORARY BASAL RATE INCREASE TO LOWER HER BLOOD GLUCOSE. WHEN SHE REMOVED THE HEADSET SHE FOUND THE CANNULA WAS BENT. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | INSULIN INFUSION PUMP| INSULIN |