MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPE S ABD+REV A1,B; ERYTYPE S ABD+REV 1,B

Catalog Number	806127100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported discrepant test results between the tango optimo and tango infinity for rh(d) when testing with erytype s abd+rev.A1, b.A patient sample yielded a 1+ positive result with both anti-d clones of erytype s abd+rev.A1,b on tango infinity, but negative results with both anti-d clones of erytype s abd+rev.A1, b on tango optimo.The customer returned the patient sample that had caused a false negative test result for investigational testing, but not the supposedly defective product.Therefore our quality control laboratory tested the patient sample with the qc lab's retained sample of erytype s abd+rev.A1, b on tango optimo.The patient sample yielded a negative reaction with both anti-d reagents on erytype s abd+rev.A1, b.At visual assessment some very small agglutinates were visible, indicating a very weak positive reaction.The sample was sent for molecular rh(d) typing to an external laboratory.We are still waiting for the result.The affected tango optimo was inspected by our field service engineers and is working within specifications.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported discrepant test results between the tango optimo and tango infinity for rh(d) when testing with erytype s abd+rev.A1, b.A patient sample yielded a 1+ positive result with both anti-d clones of erytype s abd+rev.A1,b on tango infinity, but negative results with both anti-d clones of erytype s abd+rev.A1, b on tango optimo.The customer returned the patient sample that had caused a false negative, but not the supposedly defective product.Therefore our quality control laboratory tested the patient sample with their retained sample of erytype s abd+rev.A1, b on tango optimo.The patient sample yielded a negative reaction with both anti-d reagents on erytype s abd+rev.A1, b.At visual assessment some very small agglutinates were visible, indicating a very weak positive reaction.The sample was sent for molecular rh(d) typing to an external laboratory.The result of the external laboratory is: weak d type 1.The instruction for use contains an appropriate reference: "category vii and very weak expressions of the d antigen (d weak with very few receptors) will give weakened or negative reactions with the anti-d reagents on this strip." our qc lab's retention sample of erytype s abd+rev a1,b was also tested with different red blood cells.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 and is working within specifications.

• Brand Name: ERYTYPE S ABD+REV A1,B
• Common Device Name: ERYTYPE S ABD+REV 1,B
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6386736
• Report Number: 9610824-2017-00012
• Device Sequence Number: 18842771
• Product Code: KSZ
• UDI-Device Identifier: 07611969951147
• UDI-Public: 07611969951147
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/16/2017

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: 02/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 03/16/2017
• 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 INFINITY, # 4230000151; TANGO OPTIMO, # 9142400575