FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK FLEXLINK
MDR report key: 2012120
·
Received March 4, 2011
Report
- Report Number
- 2183996-2011-00388
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- February 16, 2011
- Report Date
- February 18, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC
- Product Code
- FRN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT OCCURRED OUTSIDE THE U.S. 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.
Description of Event or Problem · 1
THE PT'S VENDOR REPORTED THE INFUSION TUBING SEPARATED FROM THE LUER CONNECTION WITHIN 4 DAYS OF USE. THIS OCCURRED ON 3 OCCASIONS AND THE PT EXPERIENCED ELEVATED BLOOD GLUCOSE (VALUE NOT PROVIDED). THE PT CHANGED THE INFUSION SET AND BLOUSED THROUGH THE INFUSION DEVICE TO LOWER BLOOD GLUCOSE. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK FLEXLINK | INSULIN INFUSION SET | FRN | ROCHE INSULIN DELIVERY SYSTEMS INC | NA | 7490100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | INSULIN INFUSION PUMP| INSULIN |