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	03/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that a cord blood sample was typed as bloodgroup a rh(d) negative with erytype s abd+rev.A1, b on tango optimo.The sample was sent to a reference laboratory and the result came back as bloodgroup ab rh(d) negative.The customer further reported that the anti-a well in erytype s abd+rev.A1, b did not have enough red blood cells.The red blood cells are pipetted out of the patient respectively donor samples by the tango optimo, whereas the antisera like anti-a and anti-b are already dried in the ready for use erytype s abd+rev.A1, b microtest plate.The customer returned neither the supposedly defective product nor the patient sample that had caused a false negative test result.Therefore our quality control laboratory tested their retained sample of erytype s abd+rev.A1, b with different red blood cells on tango optimo.All positive and negative reactions were correct.We did not observe any false negative reaction.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 inspected by our field service engineers.From today's perspective we can say that the instrument is not validated for cord blood samples.The root cause analysis is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that a cord blood sample was typed as bloodgroup a rh(d) negative with erytype s abd+rev.A1, b on tango optimo.The sample was sent to a reference laboratory and the result came back as bloodgroup ab rh(d) negative.The customer further reported that the anti-a well in erytype s abd+rev.A1, b did not have enough red blood cells.The red blood cells are pipetted out of the patient respectively donor samples by the tango optimo, whereas the antisera like anti-a and anti-b are already dried in the ready for use erytype s abd+rev.A1, b microtest plate.The customer returned neither the supposedly defective product nor the patient sample that had caused a false negative test result.Therefore our quality control laboratory tested their retained sample of erytype s abd+rev.A1, b with different red blood cells on tango optimo.All positive and negative reactions were correct.We did not observe any false negative reaction.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 inspected by our field service engineers with no indication for an instrument malfunction.The instrument was confirmed to operate within specification.The tango optimo is not validated for cord blood samples.

• 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: 6459626
• Report Number: 9610824-2017-00022
• Device Sequence Number: 608755
• Product Code: KSZ
• UDI-Device Identifier: 07611969951147
• UDI-Public: 07611969951147
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/17/2017

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: 02/25/2018
• Device Catalogue Number: 806127100
• Device Lot Number: 8635070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/17/2017
• 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: TANGO OPTIMO, # 9142400407