MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-1000 AUTOMATED ANALYZER SYSTEM

Catalog Number	001100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that anti-e antibodies were not detected when he tested with ih-cell i-ii-iii on the ih-card ahg anti-igg on two different ih-1000 instruments (see also report 9610824-2025-00011).The customer stated that anti-e antibodies were detected with immucor reagents but not the ih-card.The customer announced to send in samples of the allegedly defective products for investigational testing.While waiting for the samples to arrive on our premises, our quality control laboratory tested their retention samples of the affected lots of ih-cell i-ii-iii and ih-card ahg anti-igg.Five different e-antigen positive donor cells were titrated with a known anti-e serum in the ih-card ahg anti-igg.All five donor cells reacted positively up to the titer level of 1:8.The visual inspection of the materials showed no abnormalities.The e-antigen positive cell no.2 of ih-cell i-ii-iii did not show a weak expression of the e-antigen.Furthermore, the antigenicity was comparable to other e-antigen positive ih-cells.Further investigation is still ongoing.Trace files of the affected ih-1000 instrument are still under investigation.
Additional Manufacturer Narrative
In our initial report, we stated the date of event as february 28th, 2025 but it turned out that in fact it is february 23, 2025.This is our final report on this incident.
Event or Problem Description
The customer reported that anti-e antibodies were not detected when he tested with ih-cell i-ii-iii on the ih-card ahg anti-igg on two different ih-1000 instruments (see also report 9610824-2025-00012).The customer stated that anti-e antibodies were detected with immucor reagents but not the ih-card.Trace files of the affected ih-1000 instrument were analysed.The incubation period proceeded as anticipated, with a centrifuge waiting time of 6 minutes and 6 seconds, which remains within the device specifications.Given that anti-e antibodies are typically of the igm type and react more effectively at lower temperatures, one might expect a reaction due to the waiting time at room temperature in the centrifuge.However, no such reaction was observed.There were no malfufunctions during the other steps of sample processing on the device.The instrument worked with no issues.Our quality control laboratory tested their retention samples of the affected lots of ih-cell i-ii-iii and ih-card ahg anti-igg.Five different e-antigen positive donor cells were titrated with a known anti-e serum in the ih-card ahg anti-igg.All five donor cells reacted positively up to the titer level of 1:8.The visual inspection of the materials showed no abnormalities.The e-antigen positive cell no.2 of ih-cell i-ii-iii did not show a weak expression of the e-antigen.Furthermore, the antigenicity was comparable to other e-antigen positive ih-cells.The customer provided one patient sample that had caused the false negative test result.Different tests were carried out to detect any possible antibodies.In the ih-card anti-lgg lot 9408020 with the ih-cell i-ii-iii lot 9510011, the patient sample reacted negatively on the ih-1000.The patient sample was tested manually with the ih-panel 11 with and without papain; only cell 4 reacted positively.Anti-e could not be detected.Cell 4 is an r0r donor fya and fyb negative.Furthermore, the patient sample was tested with the panocell-16 on ih-card ahg anti­ lgg with the same test results, only cell 4 was positive (also an r0r with fya and fyb negative).Testing of the patient sample with the diacell i-ii-iii lot 994326871 in the id-card coombs anti-lgg lot 8670184036 and the id-card nacl, enzyme test and cold agglutinins lot 8868892309 reacted negative.The customer did not provide their test results of the sample id provided.Therefore, we could not confirm the cusomers results at least for the provided patient sample.This sample does not contain an anti-e.The sample only reacted with cells of the phenotype ror fy(a-b-), with an enhanced reaction strength applying enzyme trated cells.For the other samples we can only suspect some root causes as the samples were not provided: anti-e antibodies are often lgm ones, meaning they react better at lower temperatures.Depending on the test method applied lgm antibodies might react stronger.The focus of the ih-card is detection of lgg antibodies, lgm antibodies will possibly be not detected therefore.Also we cannot check if the antibody might be of low-titer and thus at the detection limit of the system.

• Brand Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Common Device Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 21718591
• Report Number: 9610824-2025-00012
• Device Sequence Number: 3728826
• Product Code: KSZ
• UDI-Device Identifier: 07611969205493
• UDI-Public: (01)07611969205493
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: BK170019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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 Catalogue Number: 001100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/19/2025
• 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: IH-1000, SN 5100013; IH-1000, SN 5100013; IH-CARD AHG ANTI-IGG, LOT 9408020; IH-CARD AHG ANTI-IGG, LOT 9408020; IH-CELL I-II-III, LOT 9503011; IH-CELL I-II-III, LOT 9503011
• Patient Sex: Unknown