Brand Name | REAGENT RED BLOOD CELLSBIOTESTCELL-I11 PLUS |
Type of Device | BIOTESTCELL-I11 PLUS |
Manufacturer (Section D) |
BIO-RAD MEDICAL DIAGNOSTICS GMBH |
industriestrasse 1 |
dreieich, hessen 63303 |
GM 63303 |
|
MDR Report Key | 7808413 |
MDR Text Key | 118538233 |
Report Number | 9610824-2018-00051 |
Device Sequence Number | 1 |
Product Code |
KSZ
|
UDI-Device Identifier | 07611969952441 |
UDI-Public | (01)07611969952441(17)180827(10)8827011-00 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup |
Report Date |
10/23/2018 |
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 | 08/27/2018 |
Device Catalogue Number | 816022100 |
Device Lot Number | 8827011-00 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/26/2018
|
Initial Date FDA Received | 08/23/2018 |
Supplement Dates Manufacturer Received | 07/26/2018
|
Supplement Dates FDA Received | 10/23/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | BIOTESTCELL 3, LOT 8827021-00; BIOTESTCELL 3, LOT 8827021-00; TANGO INFINITY, # 4230000157; TANGO INFINITY, # 4230000157 |
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