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

Catalog Number 001100

Device Problem False Positive Result (1227)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

The customer reported a false positive result of a patient with the anti-b of ih-card abo/d(dvi-)+rev.A1, b on ih-1000.The correct blood group of the patient was a rhd positive.The customer did not provide the complaint sample for investigational testing.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot with different donor samples on ih-1000.All positive and negative reactions were correct.We did not observe any false positive results.The customer sent in the patient sample for investigational testing.The investigation 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.

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported a false positive result of patient samples with the anti-b of ih-card abo/d(dvi-)+rev.A1, b when used on the ih-1000.The customer provided the patient samples that had cause the false positive reaction - red blood cells of two patients labeled as #1 and #2 and one plasma labeled as #2.She did not provide the allegedly defective product for investigational testing.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot of h-card abo/d(dvi-)+rev.A1, b with different donor samples on the ih-1000.All positive and negative reactions were correct.We did not observe any false positive reaction.Additionally, our quality control laboratory visually checked their retention samples for intact sealing, homogeneous gel, visible supernatant, and absence of droplets 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.Our quality control laboratory tested the patient samples provided by the customer with their retention sample on the ih-1000.Both patient samples showed the correct blood group a.The correctness of the blood group was confirmed in the tube test with monoclonal abo reagents.Plasma #2 showed a false negative reaction with ih-cell b in the reverse typing.This issue was addressed in (b)(4) , associated mdr report no.9610824-2021-00079.The customer did also provide trace files of the affected instrument ih-1000 for investigation.Analysis of these trace files showed that all the tests (blood group test) identified with the false positive anti b were performed with the right pipettor.The instrument misadjustment could be the root cause, resulting in an interwell contamination.Based on the analysis of the data files of the ih-1000 the complaint was classified as confirmed - upp, unexpected product performance.The most probably root cause is a combination of an instrument misadjustment and an interwell contamination.The inter-well contamination is generally caused by using ih-card that are in a sub-optimal status (drops of antisera under the aluminum foil of the ih card) and or the non-centering of the needle/ ih card wells.We recommended to replace the right needle, to check the centering needle/wells, to check the centering needle/washing pot, piercing ih card (check the size and hole centered), discarding ih cards which present drops of antisera on the incubation chamber and checking the remaining lot and their storage conditions.Our field service engineer confirmed that all items have been verified on this instrument.Our initial report on this incident was issued on the ih-card abo/d(dvi-)+rev.A1, b.Since our investigation showed that the issue was most likely triggered by the misadjustment of the ih-1000's needle, this report was issued on the ih-1000.

Manufacturer Narrative

This is our final report on this incident.

• 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: 12915961
• MDR Text Key: 281602948
• Report Number: 9610824-2021-00078
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969964529
• UDI-Public: (01)07611969964529(17)221119(10)9129010
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Catalogue Number: 001100
• Device Lot Number: 9129010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• 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 9129010; IH-CELL A1&B, LOT 9138021; IH-CELL A1&B, LOT 9138021