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 288 CARDS

Catalog Number	813422100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported a false negative reaction of one donor sample in the crossmatch test during validation of her ih-centrifuge l.The customer stated that she performed the crossmatch on a unit which was typed as c antigen positive with a patient plasma that demonstrated anti-c.The crossmatch should have been positive (incompatible), but it was negative (compatible).The customer performed the crossmatch manually using ih-incubator l and ih-centrifuge l.The customer returned the complaint sample ih-card ahg anti-igg, two donor segments (labeled as (b)(6)) and an aliquot labeled as anti-c.Our quality control laboratory performed the crossmatch with the samples and the ih-card the customer had provided and yielded a negative (compatible) result.So the testing of our quality control laboratory confirmed the customer´s finding.Additionally our quality control laboratory performed the crossmatch with the donor unit and two different anti- c samples.In both cases the crossmatch was correctly positive.Furthermore the crossmatch was performed with the aliquot anti-c of customer and three additional c antigen positive red blood cells.Only one red blood cell yielded a weak positive result, the reactions of the two other red blood cells were negative.Our quality control laboratory also performed an antibody screening test with the aliquot anti-c and ih-cell i-ii-iii.The antigen c positive reagent red blood cells yielded only a +/- positive reaction.Further tests were not possible, because the aliquot anti-c was used up.According to our investigation results the aliquot anti-c seemed to contain a weak reacting antibody at the detection limit and, therefore, the crossmatch was negative.Summary: testing by our quality control laboratory confirmed that the allegedly defective lot of ih-card ahg anti-igg 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: ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG
• Common Device Name: IH-CARD AHG ANTI-IGG 288 CARDS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 10183842
• Report Number: 9610824-2020-00037
• Device Sequence Number: 2612915
• Product Code: QHS
• UDI-Device Identifier: 07611969964857
• UDI-Public: (01)07611969964857(17)210508(10)8002020
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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: 05/08/2021
• Device Catalogue Number: 813422100
• Device Lot Number: 8002020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1