MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II; AHG ANTI-IGG SOLIDSCREEN II

Catalog Number	806516100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our intial report on this incident.
Event or Problem Description
The customer reported false negative results of her positive weak d control with anti-human-globulin, anti-igg solidscreen ii on tango optimo.The customer returned the supposedly defective product for investigational testing.Testing in our quality control laboratory is still ongoing.While waiting for the customer's product sample to arrive in (b)(6), the retained sample of anti-human-globulin, anti-igg solidscreen ii was tested with different controls and samples.All positive and negative results were correct.We did not observe any false negative results.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 false negative results of her positive weak d control with anti-human-globulin (ahg), anti-igg solidscreen ii on tango optimo.The customer returned the supposedly defective product but not the control that had caused false negative test results.At the time the complaint sample arrived on our premises the supposedly defective was already expired.Nevertheless our quality control laboratory tested the returned sample in parallel to their retention sample.The complaint sample showed no reactivity.All reactions which were supposed to be positive were false negative.The retention sample showed correct positive and negative results.Both, the complaint sample as well as the retention sample, were tested for microbiological growth.The result was no microbiological growth.Additionally the complaint sample and the retention sample were tested in an external laboratory for human serum albumin.The external laboratory could determine human serum albumin in the complaint sample, but not in the retention sample.The presence of human serum albumin can be a marker for the presence of human immunoglobulin g (igg).And human igg neutralizes the anti-igg of the ahg and therefore is a possible cause for the non-reactivity of the ahg returned by the customer.During its shelf life the retention sample of anti-human-globulin, anti-igg solidscreen ii was tested with different controls and samples.All positive and negative results were correct.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 solidscreen ii functions correctly.Only one single vial returned by the customer did not function correctly.The malfunction may be caused by neutralization at the customer´s site.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 SOLIDSCREEN II
• Common Device Name: AHG ANTI-IGG SOLIDSCREEN II
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6192508
• Report Number: 9610824-2016-00084
• Device Sequence Number: 13559644
• Product Code: KSZ
• UDI-Device Identifier: 07611969951437
• UDI-Public: 07611969951437
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

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: 11/24/2016
• Device Catalogue Number: 806516100
• Device Lot Number: 8523090-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 05/11/2017
• 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: ANTI-D BLEND, LOT 8549120-01, EXP. 12/03/2017; SOLIDSCREEN II STRIP, LOT 8615040, EXP. 04/08/2018