GRIFOLS 213656

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-14 for GRIFOLS 213656 manufactured by Medion Grifols Diagnostics Ag.

Event Text Entries

[53044202] False negative result at antibody screening resulting in a missed anti-s antibody. Patient was not transfused with incompatible non compatible units.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3002806769-2016-00718
• MDR Report Key: 5874517
• Date Received: 2016-08-14
• Date of Report: 2016-07-22
• Date of Event: 2016-07-11
• Date Mfgr Received: 2016-07-15
• Device Manufacturer Date: 2016-05-25
• Date Added to Maude: 2016-08-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS SANDRA RACORDON
• Manufacturer Street: BONNSTRASSE 9
• Manufacturer City: D 3186
• Manufacturer Country: SZ
• Manufacturer Postal: 3186
• Manufacturer Phone: 1264928516
• Manufacturer G1: MEDION GRIFOLS DIAGNOSTICS AG
• Manufacturer Street: BONNSTRASSE 9
• Manufacturer City: D 3186
• Manufacturer Country: SZ
• Manufacturer Postal Code: 3186
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: GRIFOLS
• Generic Name: REAGENT RED BLOOD CELLS FOR USE IN ANTIBODY SCREENING
• Product Code: PBC
• Date Received: 2016-08-14
• Catalog Number: 213656
• Lot Number: 643516006
• Device Expiration Date: 2016-07-16
• Device Availability: Y
• Device Age: 2 DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDION GRIFOLS DIAGNOSTICS AG
• Manufacturer Address: BONNSTRASSE 9 D?DINGEN, FRIBOURG 3186 SZ 3186

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-08-14