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

Catalog Number	804175100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discrepant dat results between visual and instruments software interpretation and further also between two tango infinity instruments and the manual tube technique.The customer returned the ahg anti-igg which was used in the direct antiglobulin test (dat) in the tube technique for investigational testing and also one patient sample.Testing in our quality control laboratory is still ongoing.In an initial test the complaint sample was tested for potency and specificity.The testing was done in parallel with the retention sample of the supposedly defective lot and a reference lot.All three reagents showed comparable results and the acceptance criteria were met.Further tests and the testing of the patient sample are still ongoing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Regarding the affected tango instruments, a field service engineer was on site and found both instruments to be working within specification.5.The log files did not show any issue relevant abnormalities.We are waiting for additional requested information.
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported discrepant dat results between visual and instruments software interpretation and further also between two tango infinity instruments and the manual tube technique.The customer returned the ahg anti-igg which was used in the direct antiglobulin test (dat) in the tube technique for investigational testing and also one patient sample.Our quality control laboratory tested the complaint sample for potency and specificity.The testing was done in parallel with the retention sample of the supposedly defective lot and a reference lot.All three reagents showed comparable results and the acceptance criteria were met.Additionally our quality control laboratory tested the ahg anti-igg solidscreen ii the customer sent in for potency and specificity.The testing was done in parallel with the retention sample of the supposedly defective lot and a reference lot.All three reagents showed comparable results and the acceptance criteria were met.The patient sample was tested on tango infinity: dat and antibody screening test with biotestcell 3 inclusive auto control were clearly negative.It was also tested on the ih-card ahg anti-igg, c3d and the dat was negative.Furthermore, it was tested using the diamed dc-screening card: here the dat was negative with anti-igg, anti-iga, antic3c and anti-c3d; but +/- with anti-igm.Additionally the patient sample was tested in the tube technique.Due to the small amount the testing was performed with biotestcell (btc) pool: +/- reactions were yielded at 5 minutes at room temperature, 30 minutes at 37 degree celsius and in the iat.A 1+ reaction was yielded with 60 minutes at 2-8 degrees celsius.The observed agglutinates were very unstable.It could also have been pseudo agglutinates.The observed reactions in the tube tests and the dc screening cards could be a possible explanation for the weak positive reactions at customer site.Further tests were not possible because the patient sample was exhausted.Regarding the affected tango instruments, a field service engineer was on site and found both instruments to be working within specification.The log files did not show any issue relevant abnormalities.Data files of the instrument were analyzed.Result image of the sample in question (b)(4) shows for tango infinity sn: (b)(6): there is a beginning reaction around the cell button.The instruments software showed an interpretation as negative, but visually it can be interpreted as a +/-.The well at sn: (b)(6) appeared to be shifted and should be centered.Analysis of the second affected tango infinity 4230000239 showed that there is a beginning reaction around the cell button.The instruments software showed an interpretation as +/- and can be visually confirmed.The well in the measurement chamber should be centered.The customer sent one result image from the already validated result (from lab journal), it was edited by customer to a negative result but shows visually a beginning reaction based on the investigation the complaint was classified as confirmed - epp (expected product performance): the complaint sample and the retention sample reacted as expected.The customer had also provided a patient sample.The patient sample showed clearly negative results on tango infinity and ih-gel card, but weakly positive reactions in the tube technique and the dc screening card.But it was not clear whether they were true agglutinates or pseudo agglutinates.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.From instrument's perspective, based on current information and data there is no indication for an instrument malfunction.The engineer confirmed that the instrument is working within specification.The customer should be aware that it is always mandatory to verify the well interpretations visually as the reactions can reach the detection limit of the image interpretation.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: ANTI-HUMAN GLOBULIN ANTI-IGG
• Common Device Name: ANTI-HUMAN GLOBULIN, ANTI-IGG; 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: 15460614
• Report Number: 9610824-2022-00060
• Device Sequence Number: 16852111
• Product Code: QHS
• UDI-Device Identifier: 07611969950706
• UDI-Public: (01)07611969950706(17)240425(10)9119070-02
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 125215
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: 04/25/2024
• Device Catalogue Number: 804175100
• Device Lot Number: 9119070-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/21/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: AHG LOT 9112070-04.; AHG LOT 9112070-04.; SOLDISCREEN II STRIP, LOT 9121050.; SOLDISCREEN II STRIP, LOT 9121050.; TANGO INFINITY, SN: (B)(6).; TANGO INFINITY, SN: (B)(6).; TANGO INFINITY, SN: (B)(6).; TANGO INFINITY, SN: (B)(6).
• Patient Sex: Unknown