MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPUNG REAGENT IH-CARD ABO/D(DVI+)+REV A1,B

Catalog Number	813122100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false positive reaction of a patient sample with anti-b of ih-card abo/d(dv+) +rev.A1, b on the ih-1000 instrument.The customer stated that the patient sample in question had the blood group o rhd positive.Furthermore, the customer stated that the patient sample showed the correct blood group in a retest with the same lot of ih-card abo(dvi+) + rev.A1, b on the ih-1000.The customer did not provide a sample of the allegedly defective product for investigational testing but she provided the patient sample that caused the false positive test result.Testing in our quality control laboratory 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.The customer also provided data files of the affected ih-1000 instrument.These files are currently under investigation as well.
Event or Problem Description
The customer reported a false positive reaction of a patient sample (no (b)(6)) with anti-b of ih-card abo/d(dv+) +rev.A1, b on the ih-1000 instrument.The customer stated that the patient sample in question had the blood group o rhd positive and that the patient sample showed the correct blood group in a retest with the same lot of ih-card abo(dvi+) + rev.A1, b on the ih-1000.The customer did not provide a sample of the allegedly defective product for investigational testing but she provided the patient sample that caused the false positive test result.First, our quality control laboratory visually inspected their retention sample of the supposedly defective lot for intact sealing, homogeneous gel, correct filling height and splashes in the reaction chamber.All acceptance criteria were met.We did not observe any splashes in the reaction chamber.Then 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.Due to the small quantity of the patient sample and the bad status of it, the patient sample could not be tested on the ih-1000, but only manually.The reaction was additionally read by the ih-reader 24.The patient sample showed the correct blood group o rhd positive.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The customer also provided data files of the affected ih-1000 instrument.Analysis of the trace files showed that the blood group test was performed on sample (b)(6) with the left pipettor.The distribution sequence of the red blood cells suspension showed that the anti d well was distributed before the anti-b well.The blood group of the sample (b)(6) was known as o positive.We noticed a false positive on the anti-b well.Sample (b)(6) was tested again on february 22nd and the result was as expected (o positive).Based on this analysis, on inter-well contamination (from the anti-d to the anti-b) seems likely.This inter well contamination can possibly be caused by one of the following scenarios: drop of antisera present on the incubation chamber of the ih card and/or a bad status of the left needle of the instrument.Our investigation was not able to clearly rule out one.Of these two options.Because of the suspected inter-well contamination, we highly recommended 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 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 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.".

• Brand Name: BLOOD GROUPUNG REAGENT IH-CARD ABO/D(DVI+)+REV A1,B
• Common Device Name: IH-CARD ABO/D(DVI+)+REV A1,B
• 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, 63303 ; GM 63303
• MDR Report Key: 16589734
• Report Number: 9610824-2023-00013
• Device Sequence Number: 3022055
• Product Code: QHR
• UDI-Device Identifier: 07611969964543
• UDI-Public: (01)07611969964543(17)231217(10)9233030
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: 125534
• 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): 05/02/2023

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: 12/17/2023
• Device Catalogue Number: 813122100
• Device Lot Number: 9233030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 (B)(6).; IH-1000, SN (B)(6).
• Patient Sex: Unknown