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

Catalog Number 806127100

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event 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.

Manufacturer Narrative

This is our final report on this incident.

Event 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
• Type of Device: ERYTYPE S ABD+REV 1,B
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303 ; 103 3130 5
• MDR Report Key: 6386736
• MDR Text Key: 69747296
• Report Number: 9610824-2017-00012
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969951147
• UDI-Public: 07611969951147
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2018
• Device Catalogue Number: 806127100
• Device Lot Number: 8634070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TANGO INFINITY, # 4230000151; TANGO OPTIMO, # 9142400575