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	11/16/2024
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 false negative reactions of her solidscreen ii positive control for antibody screening tests when used on one of their tango infinity instruments.The same aliquot was used on the customer's second instrument and passed 4+ on both cells.The customer ran twice and both times the result was negative on the first tango infinity.After the customer exchanged the ahg anti-igg solidscreen ii bottle, the quality control was passed.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 ad specificity, but the product sample provided by the customer showed false negative results in all testings.The anti-igg-activity was no longer detectable in the provided product sample.Instrument data of the affected tango infinity were analyzed.On (b)(6), 2024 the test result was positive as expected, on november 16, 2024, a false negative result was yielded.After loading a new bottle of ahg, the test result with the patient sample was positive again.The instrument data do not show any error or misfunction of the instrument which could have lead to the deactivation of the ahg or lead to false negative results.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 neutralization 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: 20923252
• Report Number: 9610824-2024-00053
• Device Sequence Number: 20094564
• Product Code: QHS
• UDI-Device Identifier: 07611969951437
• UDI-Public: (01)07611969951437(17)250124(10)9331010-03
• 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
• Report Date (Section B): 12/13/2024

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: 01/24/2025
• Device Catalogue Number: 806516100
• Device Lot Number: 9331010-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2024
• Initial Report FDA Received Date: 12/13/2024
• 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: COOMBSCELL E, LOT 9448011-00; TANGO INFINITY, SN (B)(6).
• Patient Sex: Unknown