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

Catalog Number	816022100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false negative reaction of a patient sample when tested using biotestcell-i11 plus on tango infinity.The specificity of the missed antibody is anti-jk(b).The customer returned the supposedly defective product for investigational testing and also the patient sample that had caused the false negative test result.At the time we received the supposedly defective product the lot was already expired.Our quality control laboratory is still testing the solid screen ii reagents and the patient sample provided by customer.Within its shelf life the retention sample of biotestcell-i11 plus was tested with different samples and controls, e.G.Anti-jk(b).All positive and negative reactions were correct.We did not observe any false negative reaction.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that an anti-jk(b) was missed when testing with biotestcell-i11 plus on tango infinity.The customer stated that a patient sample was tested manually in tube using an enhancement solution and yielded a reaction with anti-e and anti-jk(b).The same sample was then tested on tango infinity and yielding a positive reaction with anti-e, but not with anti-jk(b).The customer submitted the supposedly defective product for investigational testing, and also reagents mlb2 and anti-human globulin anti-igg solidscreen ii and the patient sample that had caused false negative test results.At the time we received the complaint sample it was already expired.Therefore the patient sample and the reagents provided by the customer were tested with our quality control laboratory's retention sample of the current lot of biotestcell-i11 plus (lot 8750011-00) on tango infinity.For testing on tango infinity we used the same reagents, but two different software versions: with the "old" software version three anti-jk(b) positive panel red blood cells yielded a false negative result; with the new software version no false negative reactions occurred, one jk(b) positive panel cell only yielded a +/-.Due to our test results we highly recommend the customer to install the new released software version.Testing of our quality control laboratory confirmed the correct function of the reagents submitted by the customer.The presence of the anti-e could be confirmed in all tests.Within its shelf life the retention sample of the allegedly defective lot biotestcell-i11 plus was tested with different samples and controls, e.G.Anti-jk(b) from an interlaboratory comparison test.All positive and negative reactions were correct.We did not observe any false negative reaction.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 infinity was inspected by one of our field service engineers with no indication for a malfunction of the instrument.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL I11 PLUS
• Common Device Name: BIOTESTCELL I11 PLUS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7181476
• Report Number: 9610824-2017-00097
• Device Sequence Number: 10781329
• Product Code: KSZ
• UDI-Device Identifier: 07611969952441
• UDI-Public: (01)07611969952441(17)171218(10)8743011-00
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/02/2018

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: 12/18/2017
• Device Catalogue Number: 816022100
• Device Lot Number: 8743011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1