MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-1000 AUTOMATED ANALYZER SYSTEM; 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 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

This is our intial report on this incident.

Event Description

The customer reported false positive reactions of two consecutive patient samples with anti-b of ih-card abo/d(dvi-)+rev.A1, b on ih-1000.The customer stated that the affected patients had the blood group a rh(d) positive and o rh(d) positive.The customer stated that the two false positives were repeated on their other instrument the same day and there was no problem, the samples were then run on the original serial number on (b)(6) and there was no problem.The customer informed us that a false positive reaction was again observed on (b)(6) 2021.The customer did neither provide the complaint sample nor the patient samples that caused false positives.Testing of our qc lab's retention sample 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.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported false positive reactions of two consecutive patient samples with anti-b of ih-card abo/d(dvi-)+rev.A1, b on ih-1000.She stated that the affected patients had the blood group a rh(d) positive and o rh(d) positive.The customer also stated that the two false positives were repeated on their other instrument the same day ((b)(6) 2021, report no.9610824-2021-00074) and there was no problem.The samples were then run on the original serial number on oct.19 and there was no problem.The customer informed us that a false positive reaction was again observed on (b)(6) 2021 (subject of this report).The customer did neither provide a sample of the allegedly defective product ih-card abo/d(dvi-)+rev.A1, b for investigatinal testing nor the patient samples that caused false positive test results.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot with donor samples on the ih-1000.All positive and negative reactions were correct.We did not observe any false positive reactions.Additionally, the retention sample was visually checked for intact sealing, homogeneous gel, correct filling height and absence of splashes in the reaction chamber.All acceptance criteria were met.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Trace files of the affected ih-1000 instrument were checked.The provided pictures cofirm a false postive result on the anti-b well and on the anti-b wells.The trace files analysis showed that these tests were performed with the right pipettor.Based on the false positive results and the error essages of the instrument, an inter-wells contamination is highly suspected to have caused the false positive test result.Although the problem was solved after a field service engineer was on-site, we referred to the customer the following points regarding interwell contamination: - 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 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 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." our initial report on this issue was filed for the ih-card abo/d(dvi-)+rev.A1, b.Since our investigation indicates that the ih-1000 might have caused the issue, this report is now being submitted for the ih-1000 instrument.

• 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: 12809952
• MDR Text Key: 285358978
• Report Number: 9610824-2021-00075
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969205493
• UDI-Public: (01)07611969205493
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: 001100
• Device Catalogue Number: 001100
• Device Lot Number: 9125020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• 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-1000, SN (B)(6); IH-CARD ABO/D(DVI-)+REV A1, B LOT 9125020