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

Model Number 850000010

Device Problem False Positive Result (1227)

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

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that lumps of red blood cells were causing the appearance of positive results in the anti-d reagent of erytype s rhd confirm as well as with erytype s abd+rev.A1, b when used on tango infinity.The customer stated that they saw this issue only on anti-d wells with rhd negative patient samples.The customer submitted result images of the false results.The instrument's software calculated the result strength as expected, considering the darker cell accumulation over the brighter background.Visually, the reactions do not look like a normal agglutination for the d1 and d2 well.The customer returned three patient samples that had caused false positive test results and also the supposedly defective products for investigational testing.Our quality control laboratory tested the patient samples with the complaint sample of erytype s rhd confirm, with erytype s abd+rev.A1, b as well as their product retention samples on tango infinity.The patient samples did not show any lumps that caused false positives but were completely resuspended and yielded correct negative results.Additionally the complaint samples as well as the retention samples of erytype s rh d confirm and erytype s abd+rev.A1, b were tested with different donor samples on tango infinity.All positive and negative reactions were correct.We did not observe any false positive reaction.Testing by our quality control laboratory confirmed the correct function of the allegedly defective lots of erytype s rhd confirm and of erytype s abd+rev.A1, b.A review of the batch record documentations showed no irregularities which might have negative influences on the quality of the allegedly defective lots.The affected tango infinity was inspected by our field service engineer.The most recent semi-annual preventive maintenance (pm) was performed on 8/2/2018.The metrology qualification procedure was completed with passing results.After troubleshooting the field service engineer performed metrology on camera and pipettor measurement to confirm operation and ended up in replacing the needle of the spolv and a pcb pipettor board.The fse mentioned that when he did the pipettor metrology with the old needle, the first well of the strip had blood spatter in it, so the old needle could have had a clot in it that took a long time to work its way out.Post adjustment camera setting values are within acceptable range and the log files did not show any issue relevant abnormalities.No indication for an instrument malfunction could be identified on current data.The instrument was confirmed to operate within specification by fse after his service visit.As the engineer stated, within the old needle a clot was presumed, which could have had an impact on the false result of the rh d.

• Brand Name: TANGO INFINITY
• 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: 8045514
• MDR Text Key: 129158749
• Report Number: 9610824-2018-00076
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969961719
• UDI-Public: (01)07611969961719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2018

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 Model Number: 850000010
• Device Catalogue Number: 850000010
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 11/07/2018
• 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