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); Occlusion Within Device (1423)

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

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported that two patient samples yielded negative antibody screening tests when tested with biotest cell 1&2 on tango optimo s/n 375, but a positive antibody screening test on another tango optimo on site.An anti-e could be identified in one patient sample and an anti-d in the second patient sample.The customer did neither return the supposedly defective product nor the patient samples that had caused a false negative test result.Therefore our quality control laboratory tested their retained biotest cell 1&2 sample with different controls and samples.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 biotest cell 1&2 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 a field service engineer.During this inspection the left probe was found to be partially occluded.The occlusion was corrected and the fluid flow used during maintenance rinsing was verified.After this service, control testing was performed and verified that the instrument is operating within manufacturer's specification and returned to full operation.In order to be sure that these repairs did solve the reported incident, we requested more information resp.Images.We are still waiting for this information.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported that two patient samples yielded negative antibody screening tests when tested with biotestcell 1&2 on tango optimo s/n (b)(4), but a positive antibody screening test on another tango optimo on site.An anti-e could be identified in one patient sample and an anti-d in the second patient sample.The customer did neither return the supposedly defective product nor the patient samples that had caused a false negative test result.Therefore our quality control laboratory tested their retained biotestcell 1&2 sample with different controls and samples.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 biotestcell 1&2 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 a field service engineer.During this inspection the left probe was found to be partially occluded.The occlusion was corrected and the fluid flow used during maintenance rinsing was verified.After this service, control testing was performed and verified that the instrument is operating within manufacturer's specification and returned to full operation.Further update received from field service engineer showed that the centrifuge depth was 20 steps off the bottom when it is only supposed to be at 5.The centrifuge was readjusted.This problem was occured due to an occluded left pipettor and wrong adjustments of the centrifuge.Because we received a result image, which shows a clot, the issue could have been occurred due to a clotted sample initially, which could have caused the occlusion of the left pipettor.After repair intervention, the tango optimo generated results as expected.

• 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 ; 103 3130 5
• MDR Report Key: 5395637
• MDR Text Key: 37727916
• Report Number: 9610824-2015-00061
• Device Sequence Number: 1
• Product Code: KSZ
• 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: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• 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
• Date Manufacturer Received: 12/31/2015
• 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