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

Catalog Number	816 065100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported a false negative antibody screening test of a patient sample when tested with biotestcell pool on tango infinity.The specificity of the missed antibody was an anti-k.The customer returned the supposedly defective product for investigational testing and also the patient sample which had caused a false negative test result.Because only a very small quantity of the complaint sample was provided by the customer it was not possible to test this sample on tango infinity.Therefore our quality control laboratory tested the patient sample with their retained sample of biotestcell pool on tango infinity and yielded a correct positive result.The retained sample was also tested with different samples and controls, including anti-k on tango infinity.All positive and negative reactions were correct.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotestcell pool 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 checked by a field service engineer.The engineer performed metrology and ran controls with passing results.The instrument was confirmed to operate within specification.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL POOL
• Common Device Name: BIOTESTCELL POOL
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6529087
• Report Number: 9610824-2017-00031
• Device Sequence Number: 16388609
• Product Code: KSZ
• UDI-Device Identifier: 07611969952670
• UDI-Public: 07611969952670
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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
• Report Date (Section B): 04/28/2017

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 065100
• Device Lot Number: 8707011
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/28/2017
• 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 8631140-03; BIOTESTCELL 1&2, LOT 8707021; TANGO INFINITY, # (B)(4)