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	06/05/2018
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 direct antiglobulin test (dat) of a patient sample.The customer had tested the patient sample manually using anti-human globulin (ahg) anti-igg, -c3d; polyspecific.The customer returned the supposedly defective product for investigational testing and also the patient sample that had caused a false negative test result.Our quality control laboratory tested the patient sample with the complaint sample provided by the customer and also with their retention sample in the direct antiglobulin test (dat) and yielded a correctly positive result.Additionally, the complaint and the retention sample were tested for positive and negative specificity and potency.All acceptance criteria were met for both ahg reagents.We did not observe any false negative results.Testing by our quality control laboratory confirmed that the allegedly defective lot of anti-human globulin 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.

• 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: 7672741
• Report Number: 9610824-2018-00039
• Device Sequence Number: 1474680
• Product Code: KSZ
• UDI-Device Identifier: 07611969950652
• UDI-Public: (01)07611969950652(17)190205(10)8646100-05
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 07/10/2018

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: 02/05/2019
• Device Catalogue Number: 804115100
• Device Lot Number: 8646100-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1