MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPE S ABD+REV A1,B

Catalog Number	806127100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported discrepant results of erytype s abd+rev.A1, b when tested on tango optimo due to artefacts in reverse typing.The customer stated to send in the supposedly defective product for investigational testing.Our quality control laboratory is still waiting for the supposedly defective product and the samples that had caused the false positive results.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported discrepant results with erytype s abd+rev.A1, b on tango optimo due to artefacts in reverse typing.The customer stated that negative reactions in reverse typing did not look like a normal reaction, but an artifact or glob.The tango optimo assessed these reactions as positive.The expected positive reactions looked fine.The customer did neither return the supposedly defective product nor the specimens that had caused false positive test results.Therefore our quality control laboratory tested their retention sample of erytype s abd+rev.A1,b with different donor samples.All positive and negative reactions were correct.We did not observe any false positives or artefacts in reverse typing.Testing by our quality control laboratory confirmed that the allegedly defective lot of erytype s abd+rev.A1, b functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The affected tango optimo was confirmed to run within specifications.

• Brand Name: ERYTYPE S ABD+REV A1,B
• Common Device Name: ERYTYPE S ABD+REV A1,B
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6363719
• Report Number: 9610824-2017-00009
• Device Sequence Number: 10946739
• Product Code: KSZ
• UDI-Device Identifier: 07611969951147
• UDI-Public: 07611969951147
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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,Followup
• Report Date (Section B): 05/10/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2018
• Device Catalogue Number: 806127100
• Device Lot Number: 8634070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERYTYPE S ABD REV A1,B, LOT 8632101, EXP. 02/04/20; TANGO OPTIMO, # 9142400489