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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
On (b)(6) the customer reported about a discordant test result of a sample during the validation of ih 1000, involving an anti-fya.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 # 8819011) 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.
Event or Problem Description
The customer reported a discordant result during validation involving an anti-fya on ih-1000.The customer stated that identification with ortho reagent red blood cells yielded positive results (1+) with homozygous cells (fy+b-) and +/- with heterozygous cells (fya+b+).The patient sample yielded false negative results with ih-panel 11.At the time the customer filed his complaint the supposedly defective product was already expired.Therefore a testing of our quality laboratory's retention sample was not possible.The customer did also not send in the patient sample that had caused a false negative test result.Therefore no investigation could be carried out.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: 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: 7863235
• Report Number: 9610824-2018-00058
• Device Sequence Number: 2049489
• Product Code: KSZ
• UDI-Device Identifier: 07611969952298
• UDI-Public: (01)07611969952298(17)180702(10)8819011
• 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: 07/02/2018
• Device Catalogue Number: 814070100
• Device Lot Number: 8819011
• 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 CARD, LOT 8717100, EXP. 08/28/2018; BIO-RAD GEL CARD, LOT 8717100, EXP. 08/28/2018; BIO-RAD GEL CARD, LOT 8819011, EXP.. 07/02/2018; BIO-RAD GEL CARD, LOT 8819011, EXP.. 07/02/2018; ORTHO GEL PANEL, LOT VRC245, EXP. 06/19/2018; ORTHO GEL PANEL, LOT VRC245, EXP. 06/19/2018; ORTHO IGG CARD, LOT 020718001-63; ORTHO IGG CARD, LOT 020718001-63