MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL-P3

Catalog Number 816 017

Device Problems False Negative Result (1225); Defective Device (2588)

Patient Problem Test Result (2695)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a false negative reaction of a patient sample with biotestcell-p3 when tested on two different tango optimo.The specificity of the missed antibody was anti-e.The customer stated that it was a known antibody that had been detected in the gel system.The customer returned the patient sample that had caused a false negative test result, but not the supposedly defective product for investigational testing.Therefore our quality control laboratory tested the patient sample with their retention sample of biotestcell-p3 on tango optimo and could confirm the customer´s finding.Additionally the patient sample was tested in the tube technique and showed clearly weak positive reactions but only in direct agglutinating tests.In the indirect antiglobulin test (iat) which is the method used on tango optimo the patient sample received only a +/- reaction.Furthermore the patient sample was tested in the gel technique and received a positive reaction.To summarize all qc lab's test results it can be concluded that the anti-e present in the patient sample is a weak reacting antibody most probably of igm type.The product instruction for use contains a note in the section limitation: "negative reactions will be obtained if the sample contains antibodies present in concentrations too low to be detected by the test method employed.No test method is capable of detecting all red cell antibodies." additionally, the retention sample of the supposedly defective lot was tested with different samples and controls on tango optimo and reacted as expected.Part of this testing was an anti-e of an interlaboratory testing.This anti-e was correctly detected by the supposedly defective lot of biotestcell-p3.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotestcell-p3 functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of both allegedly defective lots.Both affected tango optimo instruments were checked by our field service engineers, including their pipetting system.Both instruments were confirmed to be ready for operation with no abnormalities detected.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL-P3
• Type of Device: BIOTESTCELL-P3
• 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: 7933185
• MDR Text Key: 123393688
• Report Number: 9610824-2018-00065
• Device Sequence Number: 0
• Product Code: KSZ
• Reporter Country Code: GM
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2018
• Device Catalogue Number: 816 017
• Device Lot Number: 2833011-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0