MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D; POLYSPECIFIC; ANTI-HUMAN-GLOBULIN, ANTI-IGG, -C3D; 10ML

Catalog Number	804115100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false negative results of two proficiency sample when tested with anti-human globulin (ahg) anti-igg, -c3d; polyspecific in the tube method.The customer stated that they participated in three different cycles of api proficiency testing.The customer stated that they passed cycle 2, but failed cycle 1 and 3.In both cases the igg sensitized samples dat-02 (cycle 1) and dat-06 (cycle 3) yielded false negative results.The date of event is not known.The customer returned proficiency samples of cycle 3 that had caused false negative test results, but not the supposedly defective product anti-human globulin (ahg) anti-igg, -c3d; polyspecific.Testing in our quality control laboratory is still ongoing.A review of the batch record documentation showed no irregularities which might have had negative influences on the quality of the allegedly defective lot.

• Brand Name: ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D; POLYSPECIFIC
• Common Device Name: ANTI-HUMAN-GLOBULIN, ANTI-IGG, -C3D; 10ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 9658856
• Report Number: 9610824-2020-00001
• Device Sequence Number: 16298185
• Product Code: KSZ
• UDI-Device Identifier: 07611969950652
• UDI-Public: (01)07611969950652(17)210811(10)8921280-03
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 08/11/2021
• Device Catalogue Number: 804115100
• Device Lot Number: 8921280-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 02/06/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown