MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL 3

Catalog Number 816085100

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

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

Event Date 10/07/2017

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 a history of an anti-e when tested with biotestcell 3 on tango optimo.The customer returned the patient sample that had caused a false negative test result and the affected cell #2 of the supposedly defective product biotestcell 3.The customer provided two patient samples labelled # (b)(4).According to the customer's documentation the samples are from the same patient but with different dates of withdrawal.At the time we received the patient samples and the complaint sample the supposedly defective product was already expired.Nevertheless the patient samples were tested with the complaint sample of biotestcell 3 on tango optimo.We could confirm the customer´s finding.The patient samples were tested with a current lot of biotestcell 3 and yielded the same result.Additionally the patient samples were tested in different tube methods.Both patient samples yielded clearly strong positive results only when using the enzyme method.In the indirect anti-human globulin test the reactions were negative.The tango optimo also uses the indirect anti-human globulin method.As a summary of all test results the anti-e of patient is supposed to be an antibody with a reaction optimum in the enzyme method.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 was tested within its shelf life on tango optimo with different samples and controls, e.G.Anti-e, and reacted as expected.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotestcell 3 functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of both allegedly defective lots.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL 3
• Type of Device: BIOTESTCELL 3
• 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: 7037054
• MDR Text Key: 93350888
• Report Number: 9610824-2017-00089
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969952687
• UDI-Public: 07611969952687
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/16/2017

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 Expiration Date: 10/23/2017
• Device Catalogue Number: 816085100
• Device Lot Number: 8735031-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/16/2017
• 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