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); Fluid/Blood Leak (1250)

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

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

This is our combined initial and final report on this incident.

Event Description

The customer reported that an antibody was identified with the screening cells biotestcell 3 but missed with the panel cells biotestcell-i11.The customer performed antibody screening and identification on two different tango optimo.The customer reported that an anti-e and anti-kp(a) could be identified.The customer did return the supposedly defective product and the patient sample that had caused a false negative result for investigational testing.Our quality control laboratory tested the patient sample with the supposedly defective product provided by the customer and yielded positive results.Testing in our quality control laboratory confirmed the presence of anti-e and anti-kp(a).The supposedly defective product was tested 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 lot of biotestcell-i11 that was used during the false negative testing 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 thoroughly inspected by a field service engineer.According to the field service report, all pipettor and camera alignments were verified.An 8-channel valve was found to be leaking and was replaced.A post service verification was completed and the instrument was operating within manufacturer's specifications and returned to full operation.On the next day after the initial field service, all controls were verified.The instrument is operating within manufacturer's specifications.

• 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: 5309538
• MDR Text Key: 34617174
• Report Number: 9610824-2015-00056
• 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
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• 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: 11/20/2015
• 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