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

Model Number 001100

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported false positive reactions with the anti-b of h-card abo/d(dvi-)+rev a1,b, lot: 9224020 on ih-1000 performed on (b)(6) 2022.The customer observed the issue while testing three patient samples with known antibodies.The blood typing of the patients were performed by tube testing and manual gel on (b)(6) 2022 and were showing the following characteristics:: patient number: (b)(6) known as pre-surgical (atherosclerosis) was found a positive ; patient number: (b)(6), known as pre-surgical (endometriosis) was found o positive and patient number: (b)(6) known as pre-surgical (crones disease) was found o positive.The customer did not provide the allegedly defective product sample for investigational testing.Therefore our quality control laboratory will test the retention sample of the supposedly defective lot with different donor samples on the ih-1000.The customer provided the trace files of ih-1000 from on (b)(6) and the files were analysed by our itse customer product complaint handling team.Itse stated that no error messages related to the pipetting process of the instrument ih-1000 (pippetor, dispensed volume) were reported.Due to the fact that all patients tested were showing anti-d positive test reactions an inter-wells contamination /(carry-over) is highly suspected.Due to the assumed inter-well contamination, we highly recommended the following to the customer: to please check the needle status: if the needle is bent or the needle coating is damaged, replace the needle.To please check the centering of the needle position and the ih card wells.And we highly recommend noting the following points according to the chapter precautions of the instruction for use:of gel cards, "cards with dispersed drops observed at the top of the microtube, due to improper storage or shipping conditions, have to be centrifuged with ih-centrifuge l or ih-reader 24 with preset time and speed before use.If drops are still observed on top of the microtube after one centrifugation it is recommended to not use the card".The affected ih-1000 (sn: (b)(4) was inspected by our field service engineers.The testing results of our quality control is pending.Still we are not in the position to provide a conclusive statement.The investigation is still ongoing.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported discrepant results of three patient samples with ih-card abo/d(dvi-)+rev a1,b when used on the ih-1000 instrument.Two patient samples had blood group a rhd positive and one blood group o rhd positive, but all three showed false positive results with the anti-b of ih-card abo/d(dvi-) +rev.A1, b.The customer did not provide a sample of the allegedly defective product for investigational testing nor the patient samples that had caused the false positive test results.Therefore, our quality control laboratory tested their retention sample with different donor samples on the ih-1000.All positive and negative reactions were correct.We did not observe any false positive reaction in the anti-b well.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The customer provided the trace files of ih-1000 from october 19th and the files were analysed by our itse customer product complaint handling team.Itse stated that no error messages related to the pipetting process of the instrument ih-1000 (pippetor, dispensed volume) were reported.The volume dispensed on the respective wells was in the range, the test were performed with the right pipettor.Due to the fact that all patients tested were showing anti-d positive test reactions an inter-wells contamination /(carry-over) is highly supspected.Due to the assumed inter-well contamination, we highly recommend the following to the customer: - replace the needle if it was bent or damaged - the adjustment of the needle centring relatively to the ih card wells must be performed for all position in the pipetting area.- control and adjust the diameter of the hole pierced ih card.It must be centred and checked by the diameter tools.- check the ih card pin piercer, please replace it if it was damaged or presents some smudge in the surface.-control the washing pot, it must be clean inside, and the used liquid (system liquid) must be correctly evacuated.-finally, perform a weekly maintenance and qc test.And we also highly recommend noting the following points according to the chapter precautions of the instruction for use: · do not use cards showing signs of drying, discoloration, bubbles, crystals or other artifacts.· do not use cards with damaged foil strips.· do not use gel cards if the gel matrix is absent or if the liquid level in the microtube is not at or below the gel matrix.A clear liquid layer should be visible on top of the uniform gel matrix in each microtube.· cards with dispersed drops observed at the top of the microtube, due to improper storage or shipping conditions, have to be centrifuged with ih-centrifuge l or ihreader 24 with preset time and speed before use.If drops are still observed on top of the microtube after one centrifugation it is recommended to not use the card.".

• Brand Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Type of Device: IH-1000 AUTOMATED ANALYZER SYSTEM
• 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: 15819312
• MDR Text Key: 307696080
• Report Number: 9610824-2022-00070
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001100
• Device Catalogue Number: 001100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IH-CARD ABO/D(DVI-)+REV A1,B, LOT: 9224020; IH-CARD ABO/D(DVI-)+REV A1,B, LOT: 9224020