FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK RAPID D LINK INFUSION SET
MDR report key: 1835346
·
Received September 10, 2010
Report
- Report Number
- 2183996-2010-01882
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- September 2, 2010
- Report Date
- September 2, 2010
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- FPA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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.
Description of Event or Problem · 1
INFUSION SET WAS LEAKY BETWEEN THE INFUSION TUBE AND THE NEEDLE. BLOOD GLUCOSE ELEVATED TO 350 MG/DL AS A RESULT, AND PT CORRECTED HYPERGLYCEMIA BY BOLUSING THROUGH INFUSION DEVICE. INFUSION NEEDLE IS CHANGED EVERY 3 DAYS AND TRANSFER SET IS CHANGED EVERY 5 DAYS. TARGET BLOOD GLUCOSE IS 190-240 MG/DL. INFUSION SET WAS REQUESTED FOR EVAL. 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 RAPID D LINK INFUSION SET | INSULIN INFUSION SET | FPA | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | 32025640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention | INSULIN| INSULIN INFUSION SET |