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

Catalog Number 848 900 010

Device Problems Defective Component (2292); Incorrect Or Inadequate Test Results (2456)

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

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported that sporadically, not resuspended artifacts occured in the reverse 0 cells when processing blood typing using erytype s ab0+d and erytypecell on tango optimo.The customer stated that negative reactions in reverse typing looked like there were crumbles in it.These artifacts did cause "+/-" results instead of negative test results on tango optimo just with test cell 0.The customer provided pictures of the phenomenon and did return the supposedly defective product (erytype s ab0+d), erytypecell for investigational testing and also four specimens that had caused that phenomenon.Therefore our quality control tested all complained samples with different donor samples.All positive and negative reactions were correct.We did not observe any false positives or artefacts (crumbles) in reverse typing.Testing by the quality control laboratory confirmed the allegedly defective lot of erytype s ab0+d 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 one of our field service engineers and was confirmed to work within specifications.At this time the customer did not observe the issue any more.The root cause analysis is still ongoing.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported that sporadically, not resuspended artifacts occured in the reverse 0 cells when processing blood typing using erytype s ab0+d and erytypecell on tango optimo.The customer stated that negative reactions in reverse typing looked like there were crumbles in it.These artifacts did cause "+/-" results instead of negative test results on tango optimo just with testcell 0.The customer provided pictures of the phenomenon and did return the supposedly defective product (erytype s ab0+d), erytypecell for investigational testing and also four specimens that had caused that phenomenon.Therefore our quality control tested all complained samples with different donor samples.All positive and negative reactions were correct.We did not observe any false positives or artefacts (crumbles) in reverse typing.Testing by the quality control laboratory confirmed the allegedly defective lot of erytype s ab0+d 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 one of our field service engineers and was confirmed to work within specifications.The b cell testing well is located prior to the 0 cell well of the corresponding assay.All the patient samples were positive for the b cell.The customer confirmed a proper function of the instrument.Due to the fact that the image evaluation software brought a discrepancy as the forward testing was correctly performed, the customer is prompted reviewing the out coming result in detail.Therefore a false blood typing can be excluded.

• 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: 6861584
• MDR Text Key: 87306406
• Report Number: 9610824-2017-00069
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969961696
• UDI-Public: 07611969961696
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/17/2017

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: 08/16/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 10/17/2017
• 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