MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG; IH-CARD AHG ANTI-IGG (RABBIT); 48 CARD

Catalog Number	813421100
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2020
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 negative reaction of one donor sample with ih-card ahg anti-igg and ih-cell i-ii-iii.The customer performed the test manually.He stated that the specificity of the missed antibody was anti-fyb.The antibody was detected in the solid phase method and the gel method of a competitor.The customer did not return the complaint sample ih-card ahg anti-igg for investigational testing and our quality control laboratory is still waiting for the patient sample that caused the false negative test result.In the meantime our quality control laboratory manually tested their retention sample of ih-card ahg anti-igg and ih-cell i-ii-iii with donor samples and known antibodies, e.G.Anti-fyb, anti-fya and ant-e.All positive and negative reactions were correct.We did not observe any false negative reaction.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.
Event or Problem Description
The customer reported a false negative reaction of one donor sample with ih-card ahg anti-igg and ih-cell i-ii-iii.The customer performed the test manually.He stated that the specificity of the missed antibody was anti-fyb.The antibody was detected in the solid phase method and the gel method of a competitor.The customer did not return the complaint sample ih-card ahg anti-igg for investigational testing.Our qc laboratory manually tested their retention sample of the supposedly defective product ih-card ahg anti-igg using the ih-cell i-ii-iii lot 8027011, as used at the customer site.The testing was performed with ih-incubator l as well as ih-centrifuge l.The following samples were used for the antibody screening test: 3 donor samples expected to be negative.3 known anti-fya (polyclonal).1 known anti-e (polyclonal).1 known anti-fyb (polyclonal).All negative samples used reacted clearly negative.The reactions with the known antibodies were specific.Both fyb-antigen positive test cells reacted with a reaction strength of 3+.The customer states that both homozygous fyb-antigen positive test cells reacted negative and the compared test cells from ortho reacted only with one of two fyb-antigen positive test cells.Testing by quality control laboratory confirmed the allegedly defective lot of ih-card ahg anti-igg lot 8012210 functions correctly.Furthermore, the retention sample of the reagent red blood cells ih-cell i-ii-iii lot 8027011, as used by customer, also reacted clearly positive with known antibodies.The results of the customer could not be confirmed.We did neither receive any further information about the performed test at the customer's site nor about the reaction strength, which was yielded using the ortho test.Therefore, the non-reaction with ih-cell i-ii-iii could maybe be explained due to the presence of an anti-fyb of low concentration.We would like to point out that no single serological antibody screening technique can provide the optimum reactions conditions for all red cell specificities.As no material was submitted, the cause of missed antibody detection at the customer's site remains unknown.

• Brand Name: ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG
• Common Device Name: IH-CARD AHG ANTI-IGG (RABBIT); 48 CARD
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 10487681
• Report Number: 9610824-2020-00063
• Device Sequence Number: 19596852
• Product Code: QHS
• UDI-Device Identifier: 07611969952168
• UDI-Public: (01)07611969952168(17)210710(19)8012210
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 125529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: 07/19/2021
• Device Catalogue Number: 813421100
• Device Lot Number: 8012210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 11/25/2020
• 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: IH-CELL I-II-III, LOT 8027011; IH-CELL I-II-III, LOT 8027011