MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

Catalog Number	816 014100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2017
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 antibody screening test of a patient sample with biotest cell 1 and 2 when tested on tango infinity.The customer reported that a sample was run on tango infinity for antibody screening and yielded a negative test result.Upon repeating, the sample yielded a positive test result.The customer did not return the supposedly defective product for investigational testing but sent back three patient samples which had caused false negatives.Therefore our quality control laboratory tested their retained biotest cell 1 and 2 sample with different patient samples and controls, including an anti-d, and -e on tango infinity.All positive and negative reactions were correct.We did not observe any false negative reaction.Once the patient samples sent back from the customer arrived in our qc lab, they were tested on tango infinity, manually and in ih-card.A clear allocation for these three samples from the customer was not possible so the observation of the customer was confirmed.A relevant reference can be found in the instruction for use (ifu): "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." testing by the quality control laboratory confirmed that the allegedly defective lot of biotest cell 1 and 2 functions correctly.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 our field service engineers.Evaluation of the data and root cause analysis is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported a false negative antibody screening test of a patient sample with biotestcell 1&2 when testing on tango infinity.The customer reported that a sample was run on tango infinity for antibody screening and yielded a negative test result.Upon repeating, the sample yielded a positive test result.The customer did not return the supposedly defective product for investigational testing but sent back three patient samples which had caused false negatives.Therefore our quality control laboratory tested their retained biotestcell 1&2 sample with different patient samples and controls, including an anti-d, and -e on tango infinity.All positive and negative reactions were correct.We did not observe any false negative reaction.Once the patient samples sent back from the customer arrived in our qc lab, they were tested on tango infinity, manually and in ih-card.A clear allocation for these three samples from the customer was not possible so the observation of the customer was confirmed.A relevant reference can be found in the instruction for use (ifu): "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." testing by the quality control laboratory confirmed that the allegedly defective lot of biotestcell 1&2 functions correctly.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 our field service engineers.No indication for an instrument or software malfunction could be identified.The instrument was confirmed to operate within specification.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL 1&2
• Common Device Name: BIOTESTCELL 1&2
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6489249
• Report Number: 9610824-2017-00027
• Device Sequence Number: 627872
• Product Code: KSZ
• UDI-Device Identifier: 07611969952380
• UDI-Public: 07611969952380
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/30/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2017
• Device Catalogue Number: 816 014100
• Device Lot Number: 8707021-00
• 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: 03/17/2017
• Supplement Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 11/30/2017
• 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: AHG, LOT 8619210-05 EXP. 11/02/2017; MLB 2, LOT 8624130-00, EXP. 06/06/2018; SOLIDSCREEN II STRIP, LOT 8630010 EXP. 07/22/2017; TANGO INFINITY, # 4230000146