Brand Name | REAGENT RED BLOOD CELLS BIOTESTCELL 1&2 |
Type of Device | BIOTESTCELL 1&2 |
Manufacturer (Section D) |
BIO-RAD MEDICAL DIAGNOSTICS GMBH |
industriestrasse 1 |
dreieich, hessen 63303 |
GM 63303 |
|
Manufacturer (Section G) |
BIO-RAD MEDICAL DIAGNOSTICS GMBH |
industriestrasse 1 |
|
dreieich, hessen 63303 |
GM
63303
|
|
Manufacturer Contact |
martina
benkert
|
industriestrasse 1 |
dreieich, hessen 63303
|
GM
63303
|
103 3130 5
|
|
MDR Report Key | 6474753 |
MDR Text Key | 72573479 |
Report Number | 9610824-2017-00024 |
Device Sequence Number | 1 |
Product Code |
KSZ
|
UDI-Device Identifier | 07611969952380 |
UDI-Public | 07611969952380 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
04/10/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/13/2017 |
Device Catalogue Number | 816 014100 |
Device Lot Number | 8703011-00 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/17/2017
|
Initial Date FDA Received | 04/10/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | AHG, LOT 8631140-02 EXP. 01/25/2018; MLB 2, LOT 8624130-00, EXP. 06/06/2018; SOLIDSCREEN II STRIP, LOT 8629060 EXP. 07/15/2018; TANGO INFINITY, # 4230000158 |