MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-N (MNS2); SERACLONE ANTI-N (MNS2)

Catalog Number	808415
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
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 positive reaction of a panel cell with seraclone anti-n.The customer used the n negative panel cell as a negative control.The customer did neither provide the supposedly defective product for investigational testing nor the panel cell that had caused a false positive test result.Testing of the retention sample in our quality control laboratory is still ongoing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Event or Problem Description
The customer reported false positive reactions with seraclone anti-n.The customer stated that they used n antigen negative panel cells from bio-rad as a negative control in the tube method.Seraclone anti-n was unexpected weak positive with n negative rrbcs (cell #2 and #3, phenotype of both cells was mmss).The customer did neither return the supposedly defective product for investigational testing nor the panel cells that had caused false positive test results.Therefore our quality control laboratory tested their retention sample of seraclone anti-n and could confirm the customer´s finding.The retention sample yielded weak (1+) false positive results with rrbcs of the phenotype mmss.In one case the retention sample yielded a very weak (+/-) false positive result with rrbcs of the phenotype mmss.The retention sample was also tested for potency and specificity.The minimum titer of 4 was exceeded.The negative specificity was tested with donor and panel cells.According to the instruction for use the red blood cells were washed and suspended in isotonic saline.The ph value of the reagent was measured and met the specification.Because of the confirmed complaint an internal quality notification has been initiated.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT ANTI-N (MNS2)
• Common Device Name: SERACLONE ANTI-N (MNS2)
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 8563629
• Report Number: 9610824-2019-00019
• Device Sequence Number: 11280975
• Product Code: KSZ
• UDI-Device Identifier: 07611969952052
• UDI-Public: (01)07611969952052(17)200102(10)2803051-00
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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: 01/02/2020
• Device Catalogue Number: 808415
• Device Lot Number: 2803051-00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1