MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL-I11

Catalog Number 816021100

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

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

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported discrepant test results between tango optimo and a competitor device.When using the ortho manual gel method, an anti-e and an anti-c were identified.When using biotestcell i11 on tango optimo just an anti-e was found but not an anti-c.Our quality control laboratory tested their retention sample of the supposedly defective lot of biotestcell i11 with different samples and controls (anti-d, anti-c, neg.Control) on tango optimo.Furthermore a known anti-e and an anti-c sample were tested.Both antibodies were found to be positive and all other controls reacted as expected.The customer returned the patient sample that had caused false negative test results and also the supposedly defective product biotestcell-i11.The samples arrived on our premises on march 06, 2019 and by that time the product was already expired (march 03, 2019).Upon arrival at bmd, the reagent red blood cells i4, i8 and i9 were completely leaked.Therefore our quality control laboratory tested the patient sample with the returned samples (b)(6).The leaked bottles were replaced with qc retention samples.In addition a reference batch was also tested and both test results confirmed the findings of the customer.Additionally the patient sample was tested in the gel technique (ih-panel 11/ ih-panel i11p/ ih-panel plus 6) and received positive reactions.All antigen e and c positive reagent red blood cells reacted positive.The test results indicate that the anti-c of the patient sample is a very weak reacting antibody.The 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." the retention sample of the supposedly defective lot of biotestcell i11 was tested during its shelf life with different samples and controls on tango optimo and reacted as expected.Part of this testing was an anti-e and an anti-c.These antibodies were correctly detected by the supposedly defective lot of biotestcell-i11.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotestcell-i11 functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Regarding the affected tango optimo, the customer did not provide any images for investigation.But the daily journal detail report was provided, which confirms the reported issue.The last annual preventive maintenance was performed as per checklist on 12/28/2018 with no problems found.A field service engineer performed the metrology qualification procedure on 02/24/2019 with passing results.The log files did not show any issue relevant abnormalities.The logged date of event for this sample id is the (b)(6) 2018.The control database could not be opened.No indication for an instrument malfunction could be identified on current data.The service engineer confirmed a proper function of the instrument by metrology qualification.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL-I11
• Type of Device: BIOTESTCELL-I11
• 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: 8431336
• MDR Text Key: 142873640
• Report Number: 9610824-2019-00006
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969952434
• UDI-Public: (01)07611969952434(17)190303(10)8902011-00
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/19/2019

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 Expiration Date: 03/03/2019
• Device Catalogue Number: 816021100
• Device Lot Number: 8902011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/19/2019
• 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