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	08/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that a patient sample with an anti-s showed a false negative reaction when tested with cell #7 of biotestcell-i11 plus.The customer returned the supposedly defective product and also anti-human globulin anti-igg, but not the patient sample that had caused a false negative test result.Testing in our quality control laboratory is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that a patient sample with an anti-s showed a false negative reaction when tested with cell #7 of biotestcell-i11 plus in the tube technique.The customer returned the supposedly defective product and also the anti-human globulin (ahg) anti-igg reagent, but not the patient sample that had caused a false negative test result.At the time we received the supposedly defective product, the affected lot biotestcell-i11 plus was already expired.Nevertheless the returned product's sample cell #7 of biotestcell-i11 plus was tested with seraclone anti-s and seraclone anti-s.Cell #7 showed a clearly positive reaction with seraclone anti-s and a negative reaction with seraclone anti-s.These reactions correspond to the antibody identification table and the results of the incoming good inspection as well as the results of the donation center that provided the donor unit for cell #7.The correct function of the ahg anti-igg submitted by customer was also verified.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotestcell-i11 plus functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• 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: 5965630
• Report Number: 9610824-2016-00061
• Device Sequence Number: 339504
• Product Code: KSZ
• UDI-Device Identifier: 07611969952441
• UDI-Public: 07611969952441
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 11/28/2016

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: 08/29/2016
• Device Catalogue Number: 816022100
• Device Lot Number: 8627011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2016
• Supplement Report FDA Received Date: 11/28/2016
• 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 8527070-05