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

Catalog Number	806516100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false negative reactions of her positive control for weak d and antibody screening tests.No patient results were affected.No samples are being collected.The customer returned a productt sample of anti-human-globulin, anti-igg solidscreen ii for investigational testing.Our quality control laboratory tested it in parallel with their retention sample of the supposedly defective lot.The retention sample met the specification for potency, but the complaint sample showed false negative results.Our testing confirmed the customer´s finding.The investigation of the affected tango infinity is still ongoing.Based on the ongoing investigation we were not able to provide a conclusive statement.The retention sample reacted as expected, but the testing of the complaint sample confirmed customer´s finding.The investigation is still ongoing.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 initial report on this incident.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported false negative reactions of her positive control for weak d and antibody screening tests.No patient results were affected.The customer returned a product sample of anti-human-globulin, anti-igg solidscreen ii for investigational testing.Our quality control laboratory tested it in parallel with their retention sample of the supposedly defective lot.The retention sample met the specification for potency, but the complaint sample showed false negative results.Our testing confirmed the customer´s finding.Instrument data of the affected tango infinity were analyzed.After unloading the ahg anti-igg solidscreen ii at 06:29:21 and loading it again at 08:13:23 the control sample showed negative results.Only after loading a new ahg at 16:07:48 the control sample showed positive results again.The instrument data do not show any error or missfunction of the instrument which could have lead to the deactivation of the ahg or lead to false negative results- based on the investigation the complaint is classified as confirmed-upp (unexpected product performance).The retention sample reacted as expected, but the testing of the complaint sample confirmed the customer´s finding.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The instrument data did not show any error or missfunction of the instrument which could have lead to the deactivation of the ahg or lead to false negative results.However, we were able to trace that the same ahg vial worked until is was unloaded and than loaded again.We referred the customer to the limitation section in the instructio for use: · contamination of anti-human globulin by extraneous protein can neutralize the entire bottle of anti-igg solidscreen ii.

• Brand Name: ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II
• Common Device Name: ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 19525980
• Report Number: 9610824-2024-00017
• Device Sequence Number: 7513029
• Product Code: QHS
• UDI-Device Identifier: 07611969951437
• UDI-Public: (01)07611969951437(17)241005(10)9315110-02
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: 125098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 10/05/2024
• Device Catalogue Number: 806516100
• Device Lot Number: 9315110-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TANGO INFINITY, SN (B)(6).; TANGO INFINITY, SN (B)(6).
• Patient Sex: Unknown