MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ERYTYPE® S ABO CONFIRM; ERYTYPE S ABO CONFIRM

Catalog Number	806130100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported a false positive reaction of one control with anti-b on erytype s abo confirm when used on tango infinity.The customer used the control reagents (control 1, 2 and 3) of hemobioscience.Control 2 is supposed to be bloodgroup o rh(d) pos, but it yielded the result bloodgroup b rh(d) pos on erytype s abo confirm on tango infinity.After cleaning and rinsing the instrument customer repeated the testing with the same reagents and yielded correct results.The customer did not return the supposedly defective product, but the control that had caused a false positive test result: control 1, 2 and 3.Therefore our quality control laboratory tested their retained sample of erytype s abo confirm with the controls on tango infinity.The controls reacted as expected.Additionally the retention sample was tested with different positive and negative red blood cells.All positive and negative reactions were correct.We did not observe any false positive reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of erytype s abo confirm functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• Brand Name: BLOOD GROUPING REAGENT ERYTYPE® S ABO CONFIRM
• Common Device Name: ERYTYPE S ABO CONFIRM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6656150
• Report Number: 9610824-2017-00041
• Device Sequence Number: 211149
• Product Code: KSZ
• UDI-Device Identifier: 07611969965670
• UDI-Public: (01)07611969965670(17)180408(10)8641140
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2018
• Device Catalogue Number: 806130100
• Device Lot Number: 8641140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1