FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK PLUS
MDR report key: 2031222
·
Received March 22, 2011
Report
- Report Number
- 2183996-2011-00569
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 2, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- FRN
- PMA / PMN Number
- K100704
- Removal / Correction Number
- Z-1488-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WILL BE RETURNED FOR EVAL.
Description of Event or Problem · 1
ON (B)(6) 2011, PT REPORTED THE INFUSION CANNULA WAS BENT ON (B)(6) 2011, AND THIS RESULTED IN A LEAK OF INSULIN AT THE INFUSION SITE. BLOOD GLUCOSE ELEVATED TO 356 MG/DL, AND NORMAL BLOOD GLUCOSE IS 98-120 MG/DL. PT NOTICED, THE INFUSION SET ADHESIVE WAS WET AFTER HER BLOOD GLUCOSE ELEVATED, AND THE INFUSION SET HAD BEEN IN USE FOR APPROXIMATELY 12 HOURS. THIS WAS THE FIRST TIME SHE USED THIS TYPE OF INFUSION SET, AND THE INSERTION DEVICE WAS USED TO INSERT THE HEADSET. PT ALSO HAD PNEUMONIA. ALLEGED INFUSION SET WAS DISCARDED AND WAS NOT REQUESTED FOR EVAL. REPLACEMENT PRODUCT WAS REQUESTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.
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 | GWX186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | INSULIN INFUSION DEVICE| INSULIN |