MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-PANEL 11; IH-PANEL 11; 11X4 ML

Catalog Number	814070100
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
On august 14th the customer reported about a discordant test result of a sample during the validation of ih 1000, involving an anti-fya specimen.The screen of the patient sample tested with ortho cells showed positive results with homozygous cells (1+) and heterozygote cells (+/-) whereas the testing with bio-rad ih-panel cells yielded into negative test results.The customer did not return the supposedly defective product (ih-panel 11/ lot # 8823011) and the patient sample which had caused the discordant test result.At the time the complaint was reported, the expiration date of the product was already exceeded.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Investigation of 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 a discordant result during validation involving an anti-fya.Customer stated that the screening and identification with ortho reagent red blood cells yielded positive results (+/- to 1+) with homozygous cells (fy+b-) only and ih-panel 11 yielded negative results.At the time the customer filed his complaint, the supposedly defective product was already expired.Therefore a testing of our quality control laboratory's retention sample was not possible.The customer did not return the patient sample that had caused a false negative test result.Therefore no investigation could be conducted.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 IH-PANEL 11
• Common Device Name: IH-PANEL 11; 11X4 ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7863238
• Report Number: 9610824-2018-00059
• Device Sequence Number: 1909016
• Product Code: KSZ
• UDI-Device Identifier: 07611969952298
• UDI-Public: (01)07611969952298(17)180730(10)8823011
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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: 07/30/2018
• Device Catalogue Number: 814070100
• Device Lot Number: 8823011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/23/2018
• 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: BIO-RAD GEL PANEL,LOT 8823011,EXP.07/30/18; BIO-RAD GEL PANEL,LOT 8823011,EXP.07/30/18; BIO-RAD IGG-CARD,LOT 760000000040; BIO-RAD IGG-CARD,LOT 760000000040; IH-PANEL 11, LOT 8823011; IH-PANEL 11, LOT 8823011; ORTHO GEL PANEL, LOT VRC246, EXP. 07/17/18; ORTHO GEL PANEL, LOT VRC246, EXP. 07/17/18; ORTHO GEL SCREEN,LOT VSS012,EXP 07/17718; ORTHO GEL SCREEN,LOT VSS012,EXP 07/17718; ORTHO IGG CARD,LOT 032918001-01,EXP.01/11/19; ORTHO IGG CARD,LOT 032918001-01,EXP.01/11/19