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	10/17/2017
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 with a known anti-k when testing with biotestcell 1&2 on tango optimo.The customer returned the supposedly defective product for investigational testing and also the patient sample which had caused a false negative test result.At the time we received the material provided by customer on our premises, the supposedly defective product was already expired.Nevertheless our quality control laboratory tested the provided complained sample with the patient sample on tango optimo and yielded a correctly positive result.Additionally the complaint sample was tested with different samples and controls, including anti-k on tango optimo.All positive and negative reactions were correct.We did not observe any false negative reaction.The retention sample of biotestcell 1&2 was already tested with different samples and controls, e.G.Anti-k, within shelf life.All results were as expected.Testing by our 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 optimo was inspected by our field service engineer team with no indication for an instrument malfunction.The service engineer confirmed a proper function of the instrument by metrology qualification.Also the qc of other testing days was run without any complaint relevant issue.

• 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: 7036310
• Report Number: 9610824-2017-00088
• Device Sequence Number: 19369173
• Product Code: KSZ
• UDI-Device Identifier: 07611969952380
• UDI-Public: 07611969952380
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 11/16/2017

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: 10/23/2017
• Device Catalogue Number: 816 014100
• Device Lot Number: 8735021-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1