MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL); ANTI-HUMAN-GLOBULIN, ANTI-IGG, -C3D; 10ML

Catalog Number	804115100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/30/2018
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 a patient sample with anti-human globulin (ahg) anti-igg, -c3d; polyspecific in the manual tube method.The customer stated that the patient sample had an antibody and a positive direct antiglobulin test (dat).The customer sent the patient sample for antibody identification to an external laboratory and is still waiting for their result.The external laboratory confirmed the positive dat of the patient sample.The customer returned the supposedly defective product for investigational testing and also the patient sample that had caused a false negative test result.Additionally he submitted a second anti-human globulin (ahg) reagent.Testing of our quality control laboratory is still ongoing.While waiting for the reagents and the patient sample submitted by the customer our quality control laboratory already tested their retention sample of the supposedly defective lot for potency and specificity.All acceptance criteria were met.We did not observe any false negative result.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 a false negative reaction of a patient sample with anti-human globulin (ahg) anti-igg, -c3d; polyspecific in the manual tube method.The customer stated that the patient sample had an antibody and a positive direct antiglobulin test (dat).The customer sent in the patient sample for antibody identification to an external laboratory.The external laboratory confirmed the positive dat of the patient sample.The customer returned the supposedly defective product for investigational testing and also two specimens of the patient that had caused false negative test results.Additionally the customer submitted a second anti-human globulin (ahg) reagent.At the time our quality control laboratory received the reagents provided by customer, the supposedly defective ahg anti-igg, -c3d; polyspecific was already expired.Our qc laboratory tested the reagents nontheless and both specimens of the patient yielded correct positive results in the direct anti-globulin test (dat) with both ahg reagents provided by the customer.An anti-igg sensitization of both specimens could be confirmed.We received strong positive reactions when we performed the dat according to the instruction for use (ifu).Additionally both ahg reagents of the customer were tested for potency and specificity and all acceptance criteria were met.Furthermore the retention sample of the supposedly defective product was tested for potency and specificity within its shelf life.All acceptance criteria were met.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of anti-human globulin (ahg) anti-igg, -c3d; polyspecific functions correctly.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: ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL)
• Common Device Name: ANTI-HUMAN-GLOBULIN, ANTI-IGG, -C3D; 10ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 8019392
• Report Number: 9610824-2018-00075
• Device Sequence Number: 1352776
• Product Code: KSZ
• UDI-Device Identifier: 07611969950652
• UDI-Public: (01)07611969950652(17)181010(10)8630050-02
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/14/2019

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: 10/10/2018
• Device Catalogue Number: 804115100
• Device Lot Number: 8630050-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 02/14/2019
• 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: AHG ANTI-IGG, LOT 8740130-03; AHG ANTI-IGG, LOT 8740130-03