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

Catalog Number	816085100
Health Effect - Clinical Code	Reaction (2414)
Date of Event	03/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported discrepant results between two tango infinity analyzers with biotestcell 3.On one analyzer the result was positive but negative on the other analyzer.The customer stated that four samples of two different patients were affected.Both patients had received rh(d) prophylaxis and due to this samples were supposed to yield positive reactions with the rh(d) positive screening cells #1 and #2 of biotestcell-3.The two samples on each patient were pre- and post-delivery.The customer stated that the positive reactions were +/- respectively 1+ positive.The customer returned the four samples of the two patients (each pre- and post-delivery) that had caused false negatives for investigational testing, but not the supposedly defective product biotestcell 3.Therefore our quality control laboratory tested the patient samples with their retention sample of biotestcell 3 on tango infinity.One pre-delivery sample yielded a correctly weak positive result, but the other pre-delivery sample and both post-delivery sample yielded negative results.Three of the four samples were additionally tested in the gel technique with enzyme treated reagent red blood cells and yielded very weak positive results.Further tests and testing of the fourth patient sample was not possible, because the material was used up.As a summary of all test results the anti-d of the two patients are very weak reacting antibodies.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 3 was tested with different samples and controls on tango infinity 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.Investigation of the affected tango infinity is still ongoing.
Event or Problem Description
The customer reported discrepant results between two tango infinity analyzers with biotestcell 3.On one analyzer the result was positive but negative on the other analyzer.The customer stated that four samples of two different patients were affected.Both patients had received rh(d) prophylaxis and due to this samples were supposed to yield positive reactions with the rh(d) positive screening cells #1 and #2 of biotestcell-3.The two samples on each patient were pre- and post-delivery.The customer stated that the positive reactions were +/- respectively 1+ positive.The customer returned the four samples of the two patients (each pre- and post-delivery) that had caused false negatives for investigatioal testing, but not the supposedly defective product biotestcell 3.Therefore our quality control laboratory tested the patient samples with their retention sample of biotestcell 3 on tango infinity.One pre-delivery sample yielded a correctly weak positive result, but the other pre-delivery sample and both post-delivery sample yielded negative results.Three of the four samples were additionally tested in the gel technique with enzyme treated reagent red blood cells and yielded very weak positive results.Further tests and testing of the fourth patient sample was not possible, because the material was used up.As a summary of all test results the anti-d of the two patients are very weak reacting antibodies.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 3 was tested with different samples and controls on tango infinity 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.The affected tango infinity was checked by our field service engineers with no indication for a malfunction.The instrument is confirmed to run within specifications.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL 3
• Common Device Name: BIOTESTCELL 3
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7435749
• Report Number: 9610824-2018-00018
• Device Sequence Number: 13726190
• Product Code: KSZ
• UDI-Device Identifier: 07611969952687
• UDI-Public: (01)07611969952687(17)180409(10)8807011-00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2018
• Device Catalogue Number: 816085100
• Device Lot Number: 8807011-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TANGO INFINITY, # 4230000138; TANGO INFINITY, # 4230000138