MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH TANGO OPTIMO; AUTOMATED BLOOD BANK ANALYSER SYSTEM

Catalog Number 848 900 010

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)

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

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported discrepant test results on a patient sample known as anti-kell when testing on tango optimo.The sample showed initially negative test results with screening cell #1 (biotest cell 3).After recollecting the sample and testing it on the second testing day with biotest cell 3 , the sample showed a positive reaction (2+).They repeated two samples from the day before and obtained a +/- test on the screening cells.The customer returned the supposedly defective product (biotest cell 3), the used ahg for solid screen ii plates (scii) and the two samples that had caused the discrepant results for investigational testing.Our quality control laboratory tested the complained biotest cell 3 lot # 8727011-00 in comparison with the retained current lot biotest cell 3 # 8731021-00 with different samples, controls and with the patient samples provided by the customer.Additionally the ahg for sc ii was tested by titration in parallel to the retained sample and a reference lot.The patient samples were clearly identified to have an anti-kell.All positive and negative reactions were correct for antibody screen.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed the correctly function of the allegedly defective lot biotest cell 3, #8727011-00.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.Following our sop the complaint has to be classified as not confirmed because the allegedly defective product worked as expected and the provided samples were clearly identified to be positive for anti-kell.The affected tango optimo was inspected by one of our field service engineer.From today¿s perspective the affected tango optimo was confirmed to run within specifications.The root cause analysis is still ongoing.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported discrepant test results on a patient sample known as anti-kell when testing on tango optimo.The sample showed initially negative test results with screening cell #1 (biotestcell 3).After recollecting the sample and testing it on the second testing day with biotestcell 3 , the sample showed a positive reaction (2+).They repeated two samples from the day before and obtained a +/- test on the screening cells.The customer returned the supposedly defective product (biotestcell 3), the used ahg for solidscreen ii plates (scii) and the two samples that had caused the discrepant results for investigational testing.Our quality control laboratory tested the complained biotestcell 3 lot # 8727011-00 in comparision with the retained current lot biotestcell 3 # 8731021-00 with different samples, controls and with the patient samples provided by the customer.Additionally the ahg for sc ii was tested by titration in parallel to the retained sample and a reference lot.The patient samples were clearly identified to have an anti-kell.All positive and negative reactions were correct for antibody screen.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed the correctly function of the allegedly defective lot biotestcell 3, #8727011-00.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.Following our sop the complaint has to be classified as not confirmed because the allegedly defective product worked as expected and the provided samples were clearly identified to be positive for anti-kell.The affected tango optimo was inspected by one of our field service engineers.It was confirmed that the instrument is working according to specification.The log file does not indicate an error during processing of the sample.

• Brand Name: TANGO OPTIMO
• Type of Device: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• 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
• MDR Report Key: 6854867
• MDR Text Key: 86314270
• Report Number: 9610824-2017-00066
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969961696
• UDI-Public: 07611969961696
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080013
• 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: 09/19/2017

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 Catalogue Number: 848 900 010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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