Brand Name | ACCU-CHEK ® RAPIDLINK INFUSION SET |
Type of Device | SUBCUTANEOUS INFUSION SET |
Manufacturer (Section D) |
ROCHE DIAGNOSTICS |
9115 hague road |
indianapolis IN 46250 |
|
Manufacturer (Section G) |
FRESENIUS KABI DEUTSCHLAND GMBH |
robert-koch-strasse 5 |
na |
bad hersfeld D-36 251 |
GM
D-36251
|
|
Manufacturer Contact |
michael
leslie
|
9115 hague road |
na |
indianapolis, IN 46250
|
3175214343
|
|
MDR Report Key | 3688033 |
MDR Text Key | 4297108 |
Report Number | 1823260-2014-01904 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
06/18/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 07/31/2017 |
Device Catalogue Number | ASKU |
Device Lot Number | 32352262 |
Other Device ID Number | 00700006940 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/14/2014 |
Is the Reporter a Health Professional? |
No
|
Event Location |
Hospital
|
Initial Date Manufacturer Received |
03/11/2014
|
Initial Date FDA Received | 03/19/2014 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/18/2014
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 050 YR |