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 combined initial and final report on this incident.
Event or Problem Description
The customer reported that she missed an anti-s when using biotest cell 1 and 2 on tango infinity.The customer returned the supposedly defective product and also the patient sample which had caused a false negative test result for investigational testing.The customer also returned the affected anti-human globulin (ahg) anti-igg solidscreen ii and the affected low ionic strength solution (liss) mlb2.Therefore our quality control laboratory tested the patient sample on tango infinity with the reagents provided by the customer and yielded correct positive results.The supposedly defective product was also tested with different samples and controls, e.G.An anti-s.All positive and negative reactions were correct.We did not observe any false negative reaction during testing on tango infinity.Testing by our 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 both allegedly defective lots.The affected tango infinity was inspected by our field service engineers.A metrology check was performed according to manufacturer's checklist and the instrument was confirmed to run.Within the metrology testing, the solidscreen ii assay was performed with controls and yielded acceptable results.This incident does not meet our reporting criteria for instruments.

• 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: 6502728
• Report Number: 9610824-2017-00028
• Device Sequence Number: 1594571
• Product Code: KSZ
• UDI-Device Identifier: 07611969952380
• UDI-Public: 07611969952380
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date (Section B): 04/19/2017

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: 03/13/2017
• Device Catalogue Number: 816 014100
• Device Lot Number: 8703011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/19/2017
• 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 8608120-04 EXP. 08/19/2017; MLB 2, LOT 8624130-00, EXP. 06/06/2018; SOLIDSCREEN II STRIP, LOT 8610010 EXP. 04/03/2018; SOLIDSCREEN II STRIP, LOT 8615040 EXP. 04/08/2018; TANGO INFINITY, # 4230000105